MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-08-21 for ARTEGRAFT manufactured by Artegraft, Inc..
[117755594]
Complaint (b)(4) issue 2 of 2. The article was written based on a retrospective review of data from april 2014 to oct 2016. Artegraft, inc. Was not able to match the issues from the journal article to any previous complaints from 2014 to present. No device evaluation was able to be performed because the devices were not returned and no lot numbers were provided. No confirmed complaint trend was identified related to the issue. 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. The article link is doi: https://doi. Org/10. 1016/j. Jvs. 2018. 03. 343.
Patient Sequence No: 1, Text Type: N, H10
[117755596]
Upon literature review of a scientific article from journal of vascular surgery vol 67, number 6, june 2018 abstract titled "bovine carotid graft as a conduit in arterial trauma", 2 issues were identified; refer to mdr 2247686-2018-00005 for issue 1 of 2. This case will capture this issue related to "there was one early failure, with resultant above knee amputation, on postoperative day 1. " the article was written based on a retrospective review of records from april 2014 to oct 2016 for patients with traumatic arterial injuries who underwent vascular bypass or interposition with bovine carotid artery (artegraft). The patient was in a motorcycle collision and suffered a mangled left lower extremity. Intervention included left common femoral artery (cfa) to above knee popliteal bypass. The patient returned to the or on postoperative day 1 with nonsalvageable extremity with resultant above knee amputation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2018-00006 |
| MDR Report Key | 7801683 |
| Report Source | LITERATURE |
| Date Received | 2018-08-21 |
| Date of Report | 2018-10-11 |
| Date of Event | 2014-04-23 |
| Date Mfgr Received | 2018-09-25 |
| Date Added to Maude | 2018-08-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-08-21 |
| Device Availability | N |
| Device Age | DA |
| 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. Deathisabilit | 2018-08-21 |