MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2017-03-08 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[69360030]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[69360031]
According to the report, "study patient (b)(6) was admitted to the cvicu after he presented to the ed with intermittent substernal pressure for 2 days. He stated that it felt like his angina prior to having the cabg. At that time, he had stable vital signs and the ekg showed no st changes. However, later on in the day, the md was paged by the nurses and found the patient was having respiratory distress and complaints of chest pain. The patient was vomiting reddish-frothy phlegm, tachycardic in the 120s, diaphoretic, tachypneic in the 30s, on 2l nc and with sats initially in the 80s with stable bp. The ekg at that time showed sinus tach with incomplete lbbb and worsening congestion and bilateral lower lung bases opacities. There was concern for protection of airway, so ed was called for intubation. They suspect that the patient had pe so he was started on heparin. Patient remains sedated and intubated. "
Patient Sequence No: 1, Text Type: D, B5
[75243714]
The following additional information was obtained:? This (b)(6) year old male patient underwent tmr + cabg (redo) via redo-sternotomy with concomitant open saphenous vein harvest while on cardiopulmonary bypass on (b)(6) 2017. The patient? S medical history was significant for a preoperative eg of (b)(4), previous myocardial infarction (mi), family history of cad before age (b)(6) (blood relatives only), gout, hypercholesterolemia (=240 mg/100 ml), hypertension, previous cabg (approximately 30 years prior to current procedure), and multiple previous percutaneous coronary interventions (stents to the right coronary artery). According to records provided by the site, the patient had multiple stents in the native right coronary artery, an occluded vein graft to the right coronary artery (from the previous cabg).? The total procedure time was (b)(6) minutes, with (b)(6) minutes spent on cardiopulmonary bypass. A total of 7 tmr channels were placed to the inferior wall. Cabg was performed before the tmr procedure, in which 1 graft (saphenous vein graft) was grafted to the right coronary artery. According to the operative report provided by the site, due the severity of the patient? S coronary artery disease, no further interventions could be performed. The patient was discharged on (b)(6) 2017 (pod 7).? According to medical records from [the surgeon] (pi), the patient? S post-operative course following the tmr + cabg procedure was complicated by an acute gout attack of the right elbow. The patient was last seen in [the surgeon? S] office on (b)(6) 2017, at which time? He was found to be in good shape, and was advised that he could stop the ranexa. A few days later the patient had another attach of gout that required steroids and also started to have angina pain with effort that has increased progressively.? The patient had initially presented to the ed with stable vital signs, ekg with no st changes, negative enzymes, and no complaints of loc, cough, of ll edema.? The patient presented to the ed on (b)(6) 2017 with a 1-week history of substernal chest pain and pressure that also coincided with the discontinuation of ranexa; in addition, the patient had been angina free following the tmr+cabg procedure until stopping ranexa. According to medical records provided by the site, the patient? S chest pain was reported as? Typical, chronic, stable angina? That started while off ranexa. At this time, the patient was stable with normal vital signs. An ekg was performed in the ed which reported no acute ischemic changes and cardiac biomarkers were negative.? Later into the patient? S ed visit, the patient experienced an sudden acute onset of respiratory distress, chest pain, vomiting reddish-frothy phlegm, tachycardia in the 120? S, diaphoretic, tachypnea in the 30? S, on 2l nc with o2 sats initially in the 80? S, but with normal blood pressure. Approximately 5 minutes prior this episode, the patient began having substernal chest pain, for which he took sublingual nitroglycerin with total resolution of his symptoms, but soon after started to experience bloody retching and acute sob. A stat ekg and chest x-ray showed sinus tachycardia with incomplete lbbb, worsening congestion in bilateral lung bases opacities compared to previous cxr. On exam, the patient exhibited bilateral crackles, at bases with diffuse rhonchi on auscultation of the lungs. Exam of the heart revealed normal s1/s2, regular rhythm, tachycardia, without murmurs heard on auscultation of the heart. The patient? S condition continued to deteriorate and was subsequently intubated due to concerns of airway protection. Due to the acute onset of symptoms, pulmonary embolism was highly suspected; however, this was not confirmed. Therefore, the patient was empirically started on heparin gtt. Medical records note that during this time, the patient remained hemodynamically stable. Bedside echo demonstrated ef of (b)(4), no rv pressure/volume overload or bowing of the interventricular septum. The patient was started on lasix for diuresis and redo biomarkers taken during the episode were elevated. According to medical records, the patient was subsequently diagnosed with nstemi and acute respiratory failure secondary to flash pulmonary edema. The patient remained intubated, sedated, and was admitted to intensive care for further treatment. Repeat echo performed on (b)(6) 2017 demonstrated a newly depressed ef of (b)(4), severely impaired left ventricular systolic function with inferior wall akinesis and septal dyssynchrony. Left heart catheterization was performed on (b)(6) 2017 demonstrated: coronary artery disease? Significant native 3 vessel disease, patent lima to mlad and patent svg to om1 grafts, significant mid rca isr (in-stent restenosis) of (b)(4) in setting of markedly under expanded prior stents; right dominant system. Chest x-ray performed on (b)(6) 2017 demonstrated pulmonary edema consistent with congestive heart failure. The patient was extubated on (b)(6) 2017 did not require additional respiratory support throughout the remainder of admission. Echo performed on (b)(6) 2017 was improved from prior echo from (b)(6) 2017, and demonstrated overall left ventricular systolic function to be low-normal, with ef of (b)(4).? Thirty-day follow-up was performed on (b)(6) 2017; the patient reported no angina. The patient was discharged on (b)(6) 2017 with instructions to follow-up with referring physician. According to the available medical records, it appears that the patient experienced an acute non-st elevated myocardial infarction of the inferior wall despite confirmed patent right coronary grafts. The patient also experienced flash pulmonary edema as a result of acute ischemic congestive heart failure. The patient? S heart function improved following aggressive diuresis. The patient? S condition improved and was subsequently discharged 7 days later on (b)(6) 2017.? There is no definitive evidence to suggest that the tmr procedure performed on (b)(6) 2017 was a contributing factor to the aforementioned event.? This investigation is currently ongoing.? Any additional information will be provided in the follow-up report.?
Patient Sequence No: 1, Text Type: N, H10
[75243715]
According to the report, "study patient (b)(6) was admitted to the cvicu after he presented to the ed with intermittent substernal pressure for 2 days. He stated that it felt like his angina prior to having the cabg. At that time, he had stable vital signs and the ekg showed no st changes. However, later on in the day, the md was paged by the nurses and found the patient was having respiratory distress and complaints of chest pain. The patient was vomiting reddish-frothy phlegm, tachycardic in the 120's, diaphoretic, tachypneic in the 30's, on 2l nc and with sats initially in the 80's with stable bp. The ekg at that time showed sinus tach with incomplete lbbb and worsening congestion and bilateral lower lung bases opacities. There was concern for protection of airway, so ed was called for intubation. They suspect that the patient had pe so he was started on heparin. Patient remains sedated and intubated. "
Patient Sequence No: 1, Text Type: D, B5
[75637208]
The manufacturing records were reviewed for hand piece ta-04096. It was confirmed that all records were controlled, available for review, and met all specifications per the device master record. Based on the information available at the time of this report, it is unlikely that the tmr procedure contributed to the observed complications. The root cause is likely an acute posterior wall myocardial infarction, with subsequent acute congestive heart failure and associated pulmonary edema.? The ifu lists the following potential adverse events that may occur with the use of tmr: acute myocardial infarction, congestive heart failure, arrhythmia and pulmonary complications. Based on the information available at the time of this report, it is unlikely that the tmr procedure contributed to the observed complications. Furthermore, a thirty-day follow-up was performed on the patient and the patient reported no angina. There is no indication that an error or deficiency occurred at cryolife.
Patient Sequence No: 1, Text Type: N, H10
[75637209]
Tmr procedure date (b)(6) 2017; re-admission (b)(6) 2017 -- according to the report, "the patient was admitted to the cvicu after presenting to the? Er with intermittent substernal pressure for 2 days. The patient stated the pain felt like his angina prior to cabg procedure. At this time, the patient presented with stable vital signs and ekg showed no st changes. However, later in the day the patient was found having respiratory distress and complaints of chest pain. The patient was vomiting reddish-frothy phlegm, tachycardic in the 120s, diaphoretic, tachypneic in the 30s, on 2l nc and with stats initially in the 80s with stable lower lung opacities, there was concern for protection of airway, so ed was called for intubation. They suspect the patient had pe so he was started on heparin. Patient remains sedated and intubated. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00011 |
| MDR Report Key | 6387312 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2017-03-08 |
| Date of Report | 2017-05-08 |
| Date of Event | 2017-02-08 |
| Date Facility Aware | 2017-02-09 |
| Date Mfgr Received | 2017-02-09 |
| Date Added to Maude | 2017-03-08 |
| 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 | 2017-03-08 |
| Model Number | HP-SG3 |
| Lot Number | TA-04096 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization; 2. Other | 2017-03-08 |