MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-01-11 for ARTEGRAFT AG740 manufactured by Artegraft, Inc.
[96971692]
The complaint artegraft (collagen vascular graft) lot 17g195-007 was not returned to artegraft, inc. For evaluation as it was "repaired" by the surgeon during implant. The patient was reported to be in stable condition. A review of the production batch device history record was performed; no anomalies were identified. All grafts released from product batch 17g195 passed all of the requirements including wall thickness, pressure testing, sterility testing, and final visual inspection prior to final release to finished goods. The customer's allegation was not able to be confirmed as the graft remains implanted. No additional complaints from this product batch were reported to date. No confirmed complaint trend was identified related to thin graft wall and suture hole bleeding. The complaint issue will continue to be monitored within artegraft, inc. Quality systems, quality assurance trending. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[96971693]
Received a phone call from an approved distributor stating that during the implant of the artegraft (collagen vascular graft) a surgeon had "difficulty suturing". In follow-up communications it was clarified that the graft was "bleeding after every stitch" even using 7-0 size suture. The surgeon stated that the graft thickness was not the acceptable measurement; one end was ok, but the other end was "way too thin". "this caused major suture hole bleeding after every stich. " the surgeon "oversewed and the bleeding was controlled". The implant was completed and the patient was stable. The surgeon has seen the patient in the office after the implant and the "graft is functioning fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2018-00001 |
| MDR Report Key | 7182202 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-01-11 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-12-13 |
| Date Mfgr Received | 2018-03-01 |
| Device Manufacturer Date | 2017-08-31 |
| Date Added to Maude | 2018-01-11 |
| 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 | MS. CYNTHIA SALTER |
| Manufacturer Street | 206 NORTH CENTER DRIVE |
| Manufacturer City | NORTH BRUNSWICK NJ 089024247 |
| Manufacturer Country | US |
| Manufacturer Postal | 089024247 |
| Manufacturer Phone | 7324228333 |
| Manufacturer G1 | ARTEGRAFT, INC. |
| Manufacturer Street | 206 NORTH CENTER DRIVE |
| Manufacturer City | NORTH BRUNSWICK NJ 089024247 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 089024247 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTEGRAFT |
| Generic Name | COLLAGEN VASCULAR GRAFT |
| Product Code | LXA |
| Date Received | 2018-01-11 |
| Model Number | AG740 |
| Catalog Number | AG740 |
| Lot Number | 17G195-007 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTEGRAFT, INC |
| Manufacturer Address | 206 NORTH CENTER DRIVE NORTH BRUNSWICK NJ 089024247 US 089024247 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-11 |