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 2016-12-27 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[63336578]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[63336579]
According to report, a patient had transmyocardial revascularization (tmr) and was re-hospitalized after experiencing to angina on (b)(6) 2016. Patient was discharged on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[69115967]
According to the case report forms (crfs) and report, the patient underwent sole therapy transmyocardial revascularization (tmr) via left anterolateral thoracotomy without cardiopulmonary bypass on (b)(6) 2016. The manufacturing records were reviewed for handpiece (b)(4). It was confirmed that all records were controlled, available for review, and met all specifications per the device master record. Operative records from the site indicate that the (b)(6) patient presented with acute myocardial infarction in 2006 and had a sextuple coronary bypass with ima to lad, vein graft to the posterior descending branch of rca and vein graft to multiple circumflex branches. The patient has since required multiple interventions and his latest cardiac catheterization completed several weeks prior to tmr demonstrated a patent left mammary to the distal left anterior descending. The lad itself was patent down to a moderate sized diagonal and then was severely stenotic beyond that diagonal and then a segment beyond the stenosis was perfused with the mammary graft. There was a vein graft to the right posterior descending branch which required stents but was widely patent. There was no collateralization to the circumflex branches but still fairly good left ventricle (lv) function with ejection fraction (ef) of about 45% with global hypokinesis. Myocardial perfusion showed photon attenuation of 56%. The patient came into the operating room for tmr as there were no graftable vessels in the large circumflex distribution. The patient's reported angina score at the 30-day follow-up indicated no change in the pre-tmr angina score. According to the literature, 76-88% of patients who underwent sole therapy tmr improved by 2 or more angina classes at 3 month follow-up. However, there is evidence to support that some patients may not experience any change in baseline angina scores 3 months post-tmr (jones 1999). Both frazier et al. And jones et al. Observed that patients with fewer comorbidities experienced less relief of angina symptoms than patients with fewer comorbidities. The patient in this case had numerous pre-operative comorbidities and very advanced cad which could have limited relief of angina symptoms. Based on the available information, the root cause of the patient's recurrent angina is restenosis of a previously stented lesion and is unlikely related to the sologrip iii handpiece or the tmr procedure. The ifu lists "unstable angina" as a potential adverse event associated with the use of tmr.
Patient Sequence No: 1, Text Type: N, H10
[69115968]
According to report, a patient had transmyocardial revascularization (tmr) and was re-hospitalized after experiencing to angina on (b)(6) 2016. Patient was discharged on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2016-00074 |
| MDR Report Key | 6206694 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2016-12-27 |
| Date of Report | 2017-02-23 |
| Date of Event | 2016-11-19 |
| Date Mfgr Received | 2016-11-29 |
| Date Added to Maude | 2016-12-27 |
| 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 | 2016-12-27 |
| Model Number | HP-SG3 |
| Lot Number | TA-04093 |
| Device Expiration Date | 2018-03-28 |
| 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 | 2016-12-27 |