MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-05-03 for GELSEAL UNKNOWN UKNOWN manufactured by Vascutek Ltd.
[107830976]
(b)(4). Method: no testing methods performed - no information on the graft identification was provided. The manufacturing and qc records for this batch could not be reviewed as no information on batch details was provided. Vascutek have requested further information on this event but was informed that, because graft was implanted in 1990 no batch or serial number is available. Similar events review was carried out for all knitted grafts for leakage which gave a low occurrence rate of 0. 02% (complaints v sales). Vascutek is awaiting piece of graft to be returned for further analysis.
Patient Sequence No: 1, Text Type: N, H10
[107830977]
The event, which occurred at (b)(6) was reported to vascutek as blood leakage from the graft. The timeline of events is as follows: on (b)(6) 1990 vascutek graft was implanted in the patient for an abdominal aortic aneurysm (aaa). A large amount of beriplast was used according to the record. An aneurysm was identified and bleeding was suspected on the crutch area of the graft. On (b)(6) 2014 a stent graft, afx (jll) was placed. No change on the aneurysm. On (b)(6) 2016 a straight stent graft was placed on the right side, as the anastomotic site of the right graft got torn and bleeding occurred. On (b)(6) 2018 as leakage between the afx and the straight stent graft was suspected, additional 11mm straight bypass graft was implanted. For analysis, a piece of the graft was taken from the area where leakage occurred. No further device information has been received other than it was a 18x09mm bifurcate gelseal graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612515-2018-00003 |
| MDR Report Key | 7482389 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-03 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-04-04 |
| Date Facility Aware | 2018-04-06 |
| Report Date | 2018-06-04 |
| Date Reported to Mfgr | 2018-06-04 |
| Date Mfgr Received | 2018-04-06 |
| Date Added to Maude | 2018-05-03 |
| 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 | MRS CAROLYN FORREST |
| Manufacturer Street | NEWMAINS AVENUE INCHINNAN BUSINESS PARK |
| Manufacturer City | RENFREWSHIRE, PA4 9RR |
| Manufacturer Country | UK |
| Manufacturer Postal | PA4 9RR |
| Manufacturer G1 | VASCUTEK LTD |
| Manufacturer Street | NEWMAINS AVENUE INCHINNAN BUSINESS PARK |
| Manufacturer City | RENFREWSHIRE, PA4 9RR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | PA4 9RR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GELSEAL |
| Generic Name | GELSEAL BIFURCATE |
| Product Code | MAL |
| Date Received | 2018-05-03 |
| Model Number | UNKNOWN |
| Catalog Number | UKNOWN |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 28 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VASCUTEK LTD |
| Manufacturer Address | NEWMAINS AVENUE INCHINNAN BUSINESS PARK RENFREWSHIRE, PA4 9RR UK PA4 9RR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-03 |