MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-21 for ARTEGRAFT manufactured by Artegraft, Inc.
[95591947]
Multiple requests were made to retrieve additional information; however, to date, no additional information was provided. Product code, lot number, date of implant, exact date of the event, patient identifier and information were not provided. A review of the production batch records was not able to be completed as the product lot number was not provided. Aneurysm is a known issue; artegraft, inc. Ifu adverse reaction section states that "true aneurysms have been reported. In view of this, patients with implanted artegrafts should be observed so that appropriate action can be taken if an aneurysm should occur. This adverse reaction should also be considered when treating conditions in which extended periods of implantation are expected". To date, no confirmed complaint trend was identified related to aneurysmal grafts. All product quality and clinical issues 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
[95591948]
Artegraft, inc. Received a phone call from a vascular surgeon stating that in 2013 two patients had a femoral popliteal bypass procedure with artegraft (collagen vascular graft); the grafts were reported as becoming aneurysmal. This file will capture patient 2 of 2. The patient required surgery on (b)(6) 2017 to repair the aneurysm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2017-00013 |
| MDR Report Key | 7138873 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-11-23 |
| Date Mfgr Received | 2017-11-23 |
| Date Added to Maude | 2017-12-21 |
| 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 | 2017-12-21 |
| 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 | 2017-12-21 |