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 2016-05-03 for ARTEGRAFT AG730 manufactured by Artegraft, Inc..
[44291973]
Upon follow-up communications the doctor was able to verify the lot number of the implanted artegraft based on the patient's files. Artegraft, inc. Performed a review of the batch history records; upon release, the batch met all requirements including sterility results. Note: udi was not applicable at the time of product manufacture/release in 2010. The graft was not returned for evaluation as it remains implanted. It should be noted that aneurysms are listed in the current artegraft, inc. Instructions for use as a known potential adverse reaction. In addition, artegraft's current patient information guide instructs patients to request the dialysis caregiver to rotate needle access sites and to watch for any unusual complications, such as "ballooning" of the graft. A review of complaint files in the past 2 years was reviewed; no trend was identified for aneurysm. 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. Graft remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[44291974]
Artegraft, inc. Received an email communication from an authorized distributor, on behalf of the doctor, requesting information to be relayed back to the patient. The doctor had completed a fem-pop on the patient on (b)(6) 2010 utilizing an artegraft (collagen vascular graft); within a few years, aneurysms started to form in the artegraft so he has been watching the graft closely since then. The doctor finally replaced the graft in the last month [(b)(6) 2016] with ptfe. The doctor was "very surprised as this is the only artegraft he's had issues with after utilizing several thousand". The doctor wondered if artegraft, inc. Would be able to track the graft back to the lot number from the patient's implant date and be able to provide any feedback on the quality control of the graft that he could show to the patient showing the integrity of the graft. Upon follow up communications, the doctor clarified that the artegraft was not explanted when the new ptfe graft was implanted. He agreed to review the patient or files to attempt to identify the artegraft lot information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2016-00005 |
| MDR Report Key | 5628203 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-07 |
| Date of Event | 2016-02-09 |
| Date Mfgr Received | 2016-04-07 |
| Device Manufacturer Date | 2010-04-15 |
| Date Added to Maude | 2016-05-03 |
| 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 | 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 | 2016-05-03 |
| Model Number | AG730 |
| Catalog Number | AG730 |
| Lot Number | 10C031-011 |
| Device Expiration Date | 2013-03-31 |
| 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 | 2016-05-03 |