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 2018-10-17 for GELSOFT 632010DB manufactured by Vascutek Ltd.
[123984492]
(b)(4). A review of the retained manufacturing and quality records (with specific emphasis of the base material permeability and device porosity testing) confirmed that the product was manufactured to the intended specifications. The whole batch of (b)(4) passed porosity testing well below acceptance limit of 152ml/min with minimum reading of 23ml/min and highest reading of 28ml/min. A review of similar events was performed for all knitted devices that have been reported to have leaked. The incident rate for reported leakage events was confirmed as 0. 019% (complaints v sales). The review included all similar events reported to vascutek between jan2013 - sep 2018 inclusive. No negative trend was identified during the review.
Patient Sequence No: 1, Text Type: N, H10
[123984493]
Vascutek ltd was notified of an event that occurred in (b)(6), the event was described as follows: on (b)(6) 2017: the graft was implanted for abdominal aortic aneurysm (aaa). On (b)(6) 2018: the patient visited the hospital complaining about pain. The departments of cardiovascular surgery and radiology identified blood leakage from the leftmost one of the gelsoft branches by ct scanning. A stent graft was then added to the leakage area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612515-2018-00020 |
| MDR Report Key | 7974072 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-09-18 |
| Report Date | 2018-09-21 |
| Date Reported to Mfgr | 2018-09-21 |
| Date Mfgr Received | 2018-09-21 |
| Device Manufacturer Date | 2016-07-28 |
| Date Added to Maude | 2018-10-17 |
| 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 | GELSOFT |
| Generic Name | GELSOFT PLUS |
| Product Code | MAL |
| Date Received | 2018-10-17 |
| Catalog Number | 632010DB |
| Lot Number | 390278 9150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 26 MO |
| 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 | 2018-10-17 |