MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2017-04-17 for ARTEGRAFT manufactured by Artegraft, Inc..
[72968917]
Artegraft was not able to match the issues from the journal article to any previous complaints from 2011 to present. No device evaluation was able to be performed because the devices were not returned and no lot numbers were provided. Artegraft, inc. Ifu adverse reaction section states that steal syndrome and aneurysms are known complications with the artegraft. 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
[72968918]
Literature review of journal reprint titled: bovine carotid artery biologic graft outperforms expanded polytetrafluoroethylene for hemodialysis access. A retrospective analysis was performed of all patients who received avgs for dialysis access because they were not candidates for native avf at johns hopkins bayview medical center between january 01 2011 and june 30 2014. The study reviewed 120 consecutive grafts placed in 98 patients; 52 were bca (bovine carotid artery). The bca graft used was the artegraft (artegraft, inc. (b)(4)). Results mentioned steal occurred in two bca grafts (4%) and pseudoaneurysms occurred in two bca grafts (4%). Additionally, it was stated that the infection rate during the study period was 15% for bca. The study did not take into account medication use or the type and number of prior vascular accesses and the effect this might have on subsequent graft abandonment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2017-00003 |
| MDR Report Key | 6498770 |
| Report Source | LITERATURE |
| Date Received | 2017-04-17 |
| Date of Report | 2017-04-04 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2017-04-04 |
| Date Added to Maude | 2017-04-17 |
| 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 DR. |
| 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 | 2017-04-17 |
| 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 | 2017-04-17 |