MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-07-05 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[79063171]
The manufacturing records for the hp-sg3, sn (b)(4), were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record. All lots passed functional testing and met release specifications. This (b)(6) male patient underwent tmr + cabg via sternotomy with concomitant endo vein harvest and maze procedure with isolation of pulmonary veins (3 separate ablations on the right-sided pulmonary veins on the atrial cuff and 3 separate ablations on the left-sided pulmonary veins on the atrial cuff) and placement of left atrial appendage clip (35 mm atricure device) while on cardiopulmonary bypass on (b)(6) 2017. The patient? S medical history was significant for severe, diffuse, multi-vessel coronary artery disease, intermittent atrial fibrillation, preoperative eg of 50%, previous myocardial infarction (mi), hypercholesterolemia (= 240 mg/100 ml), hypertension, previous percutaneous coronary intervention, niddm (non-insulin dependent diabetes mellitus), ckd (chronic kidney disease), 1st degree av block, obstructive sleep apnea, cholecystectomy, gout, atrial fibrillation (on pradaxa per notes provided by the site), gerd, sickle cell trait, arthritis, and obesity. The total procedure time was 275 minutes, with 99 minutes spent on cardiopulmonary bypass. A total of 14 tmr channels (3 anterolateral, 3 posterolateral, 8 inferior) were placed. Cabg was performed before the tmr procedure, consisting of left internal mammary artery to left anterior descending artery, saphenous vein graft to diagonal, saphenous vein graft to obtuse marginal, and saphenous vein graft to distal right coronary artery. According to the operative report provided by the site, the patient had rather poor targets on the right of the obtuse marginal. The patient was discharged on (b)(6) 2017 (pod 9). Thirty-day follow-up was performed on (b)(6) 2017 at which time the patient reported no angina. No adverse events occurred during the 30-day follow-up period. The patient presented to the ed on (b)(6) 2017 with a 3-hour history of new intermittent (waxing and waning per ed notes provided by site) moderate substernal chest pain, pressure, and associated shortness of breath. Vitals and physical exam were normal, ekg was unchanged from previous (wnl) and did not demonstrate any acute st changes, chest x-ray was clear and initial troponin and labs were without acute abnormality. The patient was admitted on (b)(6) 2017 for further evaluation due to significant cardiac history. A non-stress test (dobutamine stress echocardiogram) was performed on (b)(6) 2017 and demonstrated normal results with no new dobutamine induced wall motion abnormalities and some improvement in contractility of the inferior and inferolateral walls. An echo was also performed on (b)(6) 2017 and did not demonstrate changes diagnostic of ischemia with pharmacological stress. The patient? S chest pain resolved without treatment and did not recur after arriving to the ed or during the duration of the hospital stat. The patient was discharged on (b)(6) 2017 with instructions to follow-up with their cardiologist and pcp. The patient was discharged with a diagnosis of atypical chest pain. No evidence of ischemic myocardial injury was noted and therefore the symptoms cannot be definitively attributed to a cardiac, or tmr, related cause. The root cause for the reported event remains undetermined. There is no definitive evidence to suggest that the tmr procedure performed on (b)(6) 2017 was a contributing factor to the aforementioned event. Based on the information available at the time of this report, it is not possible to determine a definitive cause of the observed complications or if they are related to the sologrip iii handpiece or the tmr procedure. The ifu (instructions for use) indicates the following adverse events are potentially associated with the use of tmr: pulmonary complications. No further action necessary. This event does not identify additional hazards or modify the probability and severity of existing hazards.
Patient Sequence No: 1, Text Type: N, H10
[79063172]
"patient was admitted through the (b)(6) ed on (b)(6) 2017 with chest pain, troponin neg x 2, ck elevated, no acute st changes on ekg. Pt was then transferred to uf for lhc. However, was noted to be taking pradaxa, so nst done instead, which was negative (see report above). Pt was discharged stable on (b)(6) with cardiology f/u. " field assurance notification form. Hp-sg3, patient (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00022 |
| MDR Report Key | 6686261 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-05 |
| Date of Report | 2017-07-05 |
| Date of Event | 2017-06-01 |
| Date Facility Aware | 2017-06-05 |
| Date Mfgr Received | 2017-06-05 |
| Date Added to Maude | 2017-07-05 |
| 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 | 2017-07-05 |
| Model Number | HP-SG3 |
| Catalog Number | HP-SG3 |
| Lot Number | TA-04096 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2017-07-05 |