MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study,user facility report with the FDA on 2017-08-15 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[82708726]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[82708727]
According to the report, "i was putting subject on my calendar for his 30 day follow up and when i went into his chart, i was notified that he is deceased. According to the notes in his chart, 'on the evening of (b)(6), the patient developed respiratory distress with oxygen saturation in the 60-70's and increased agitation. Plan was for intubation. Prior to intubation the patient went in to ventricular tachycardia. [patient] was shocked x 1 with return to normal sinus rhythm. [patient] was unresponsive with low o2 sat. The patient developed bradycardia, then went into pea arrest. Acls was initiated. There was concern for aspiration. During intubation, copious amount of bilious fluid was noted in the oral cavity and around patients face. The underwent three rounds of cpr. The decision was made to perform a bedside sternotomy. The heart was noted to be beating in a sinus rhythm. There was no evidence of bleeding or tamponade, grafts were intact. The patient was taken emergently to the or for further exploration and closure. He was admitted to the cvicu post op with sicu consulted for further management. ' on (b)(6) 2017, the patient was still unresponsible to pain with no purposeful movements. On (b)(6) 2017, the patient was still intubated and non-responsible. On (b)(6) 2017, there was concern for anoxic brain injury. Patient was evaluated for brain death. Palliative care was consulted at this time and based on the results of the brain death evaluation, patient? S wife decided to start the process for compassionate wean - pressors and mechanical ventilation were stopped. Patient was pronounced dead at 16:15 on (b)(6) 2017. I am working on collecting and redacting all documentation related to this hospital stay and the procedure. "
Patient Sequence No: 1, Text Type: D, B5
[105929899] A (b)(6) male patient underwent tmr [transmyocardial revascularization ] + cabg [coronary artery bypass surgery] via sternotomy while on cardiopulmonary bypass and concomitant on endovein harvest on (b)(6) 2017. The patient's medical history was significant for severe multi-vessel coronary disease, unstable angina, diabetes, hypercholesterolemia, hypertension, previous percutaneous coronary intervention (e. G.. Pcta [percutaneous transluminal angioplasty], stent), smoking (cigarettes: 2 packs/day for 30 years; marijuana: daily), copd (chronic obstructive pulmonary disease), diverticulitis (colon surgery in 2015), seizures, chronic kidney disease, peripheral artery disease, and peripheral vascular disease (stent in left leg). The total procedure time was 290 minutes, with 67 minutes spent on cardiopulmonary bypass. A total of 28 tmr channels (5 anterolateral, 6 posterolateral, 6 inferior, 11 anterior) were placed. Coronary bypass grafting was performed x3 with left internal mammary artery to left anterior descending artery (lad); saphenous vein graft to distal left anterior descending artery; and saphenous vein graft to obtuse marginal. Two vessels were left ungrafted (right coronary and diagonal arteries) as they were found to be too small and too disease for bypass. Tmr was performed before the cabg procedure. Additional information and medical records were provided by the site. According to hospital notes, following the tmr+cabg procedure, the patient's recovery was uneventful and the patient had remained stable from a cardiac perspective. Per medical records, the patient experienced the following post-operative events: on (b)(6) 2017, the patient developed nausea, vomiting, and abdominal distention. Ng(nasogastric) placed to suction, patient made npo (nothing by mouth), reglan added, and bowel regimen increased. On (b)(6) 2017, the patient had abdominal pain, distention, and had hypoactive bowel sounds. Per gi consult notes, kub (kidney, ureter, and bladder) x-ray demonstrated ileus vs. Early small bowel obstruction. On (b)(6) 2017, the patient was reported as much improved over (b)(6) 2017, with greatly decreased abdominal distention with w/825 cc's of bilious fluid removed via ng tube overnight. According to hospital records provided by the site, the patient had pulled out the ng tube on several occasions and had been reported as "combative" when staff attempted to reinsert ng tube. As a result the ng was left removed at on (b)(6) 2017. The patient's recovery was uneventful and was progressing well and as expected from a cardiac perspective. On the evening of (b)(6) 2017, hospital records reveal the patient experienced the following event, "on initial evaluation patient was noted to be saturating at 60s-70s, hr and sbp wnl [heart rate and systolic blood pressure within normal limits], and agitated while being actively bagged in bed in cvicu [cardiovascular intensive care unit]. Decision was made to intubate pt but prior to that pt was noted to be in monomorphic v tach. He was defibrillated at bedside with 120j and hr returned to nsr with pvcs. He was not responsive and continued to desaturate then became bradycardic. Atropine was given x 1 but pt progressed to pea and acls was initiated. Pt was intubated during code, findings significant for copious amount of biliary fluid in oral cavity and around patients face. Decision was made to perform bedside re sternotomy due to cardiac arrest post op cabg and cals guidelines. Chest was reopened at bedside, no evidence of bleeding or tamponade and grafts intact. Pt was then taken to or for further exploration and closure. Returned to cvicu in critical condition and required vasopressin, levophed, and epi gtt [drip] to maintain map and gt; 65 [mean arterial pressure]. Continued on ventilator with neuro exam concerning for hypoxic brain injury due to fixed and dilated pupils with absence of corneal and gag reflex. Bronchoscopy at bedside revealed bilious fluid on lavage, sample obtained and sent to lab and lungs irrigated and suctioned until clear. Ekg and cxr obtained, kub with evidence of ileus and diffuse dilated bowel. Og tube placed prior to or with >3500 cc biliou s flu id over the evening. Admitted to sicu [surgical intensive care unit], family updated throughout evening. " a ct was performed (b)(6) 2017 and demonstrated no acute intracranial hemorrhage, mass-effect or territorial infarct. ? Left frontal scalp subgaeal hematoma. Paranasal sinus disease. Does show loss of grey/white differentiation.? On (b)(6) 2017, the patient was made dnr (do not resuscitate) by family request and passed away following withdraw of mechanical ventilation and pressor support. The incidence of gastrointestinal complications following cts (cardiothoracic surgery) ranges from lt;1% to 4. 1% patients, and is associated with mortality rates between 13. 9% and 63% (schwartz 2013). A comprehensive list of commonly cited risk factors compiled from the literature includes: (a) decreased left ventricular ejection fraction (<40%) including post-operative low cardiac output; (b) advanced patient age; (c) pre-existing conditions such as diabetes , renal failure, peripheral vascular disease; (d) valvular surgery or combined coronary artery bypass/valve operation; (e) prolonged mechanical ventilation; (f) emergency surgery; (g) prolonged pump time; (h) need for intra-aortic balloon pump (iabp) or vasopressors during or after surgery; (i) need for re-exploration following surgery (re-sternotomy or re-thoracotomy); u) pre-existing gastric ulcer disease; (k) stroke; and (i) postoperative sepsis/infectious complications including sternal wound infection (schwartz 2013). The incidence of ileus in cardio-thoracic surgical patients is between 1-2%. Ileus is among the more common complications following cardio-thoracic procedures. Various forms of ileus following cts constitute approximately 10% of gic (gastrointestinal complications). Gastrointestinal motility dysfunction following cardio-thoracic procedures can take a number of clinical manifestations, from isolated gastric distention to prolonged bowel dysfunction (schwartz 2013). Incidence of all-cause operative mortality (in-hospital or 30-day) following tmr+cabg vs. Cabg alone have been reported by allen et al. , with rates of 1. 5% vs. 7. 6% ( p =. 02), respectively (allen 2000). Similar results were reported by frazier et al, with lower rates of all-cause operative mortality for tmr+cabg patients vs. Those who underwent cabg alone (13% vs. 28%, respectively). The most likely cause of death was hypoxic brain injury as a result of aspiration of bilious gastric contents related to ileus. The ileus was most likely related to post-surgical complications caused by opioid pain medication administration. The patient also had multiple risk factors for post-operative ileus, including pre? -existing conditions of diabetes, renal failure/kidney disease, peripheral vascular disease, and diverticular disease. There is no evidence to suggest that the event was related to the tmr procedure. The manufacturing records for the product were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record. No non-conformances (ncr? S) or deviations were associated with the product. There is no indication that an error or deficiency occurred at cryolife.
[105929900]
According to the report, "i was putting subject on my calendar for his 30 day follow up and when i went into his chart, i was notified that he is deceased. According to the notes in his chart, 'on the evening of (b)(6), the patient developed respiratory distress with oxygen saturation in the 60-70's and increased agitation. Plan was for intubation. Prior to intubation the patient went in to ventricular tachycardia. [patient] was shocked x 1 with return to normal sinus rhythm. [patient] was unresponsive with low o2 sat. The patient developed bradycardia, then went into pea arrest. Acls was initiated. There was concern for aspiration. During intubation, copious amount of bilious fluid was noted in the oral cavity and around patients face. The underwent three rounds of cpr. The decision was made to perform a bedside sternotomy. The heart was noted to be beating in a sinus rhythm. There was no evidence of bleeding or tamponade, grafts were intact. The patient was taken emergently to the or for further exploration and closure. He was admitted to the cvicu post op with sicu consulted for further management. ' on (b)(6) 2017, the patient was still unresponsible to pain with no purposeful movements. On (b)(6) 2017, the patient was still intubated and non-responsible. On (b)(6) 2017, there was concern for anoxic brain injury. Patient was evaluated for brain death. Palliative care was consulted at this time and based on the results of the brain death evaluation, patient? S wife decided to start the process for compassionate wean- pressors and mechanical ventilation were stopped. Patient was pronounced dead at 16:15 on (b)(6) 2017. I am working on collecting and redacting all documentation related to this hospital stay and the procedure. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00028 |
| MDR Report Key | 6794910 |
| Report Source | STUDY,USER FACILITY |
| Date Received | 2017-08-15 |
| Date of Report | 2017-10-18 |
| Date of Event | 2017-07-05 |
| Date Facility Aware | 2017-07-17 |
| Date Mfgr Received | 2017-07-17 |
| Date Added to Maude | 2017-08-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLOGRIP III HANDPIECE |
| Generic Name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
| Product Code | MNO |
| Date Received | 2017-08-15 |
| Model Number | HP-SG3 |
| Catalog Number | HP-SG3 |
| Lot Number | TA-04099 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-08-15 |