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 2016-06-25 for ARTEGRAFT AG745 manufactured by Artegraft, Inc..
[48191309]
Artegraft, inc. Performed a review of the batch history record. Upon release, the batch met all requirements including pressure test results and graft wall thickness. Product evaluation was not able to be performed as the graft remains implanted and the patient is reported to be in stable condition. Photographs of the surgery prior to the suture of the graft "slit" were provided; however, no conclusions were able to be made based on the images. To date, no additional complaints were reported from the same product batch and no complaints for the same issue of implanted graft "blow out' were received in the past 2 years. It is unknown if procedural issues and/or patient interaction contributed to the reported event. The complaint issue will continue to be monitored within artegraft, inc. Quality systems, quality assurance trending. Graft remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[48191310]
An artegraft, inc. Approved distributor reported on behalf of the vascular surgeon that an artegraft (collagen vascular graft) which was implanted a "couple of weeks ago" "blew out"; a hole was noticed in the side of the graft. Upon follow-up communications, it was stated that the patient previously had blood flow issues and as a result, lost toes due to failed limb salvage. The artegraft was implanted in the patient's right femoral to popliteal during a limb salvage procedure on (b)(6) 2016. The reporter was unsure if the artegraft ifu required step for pre-implant pressure testing was performed by the surgical team. It was also stated that this was the hospitals first attempt at using an artegraft in a lower extremity. A few weeks after the surgery, the patient alleged noticeable irritation under the skin in the graft location. The surgeon initially attempted to place a vascular stent however, it failed in performance. Further exam identified a graft rupture. When the patient's leg was operated on (b)(6) 2016, coagulated blood was seen and about 3 cm from the anastomosis there was a ~1 cm "slit" in the graft. The surgeon was able to successfully suture the "slit" in the graft. The graft remains implanted and the patient is reported to be in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2016-00008 |
| MDR Report Key | 5750026 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-06-25 |
| Date of Report | 2016-05-27 |
| Date of Event | 2016-05-27 |
| Date Mfgr Received | 2016-05-27 |
| Device Manufacturer Date | 2016-06-08 |
| Date Added to Maude | 2016-06-25 |
| 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 | 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 | 2016-06-25 |
| Model Number | AG745 |
| Catalog Number | AG745 |
| Lot Number | 15D102-014 |
| Device Expiration Date | 2018-04-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-06-25 |