MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-06-30 for ARTEGRAFT AG750 manufactured by Artegraft, Inc..
[78863457]
The subject artegraft (collagen vascular graft) was not returned to artegraft, inc. For evaluation. A review of the production batch record was performed; no anomalies were identified. All grafts released from product batch 16k249 passed all of the requirements including pressure testing prior to final release to finished goods. Artegraft, inc. Scientific advisor (qualification: m. D. , f. A. C. S. ) reviewed the case details and stated that "the extensive nature of the vascular disease was consistent with the patients underlying co- morbidities. The fact that these patients were not immediately amputated is a testament to the skill of the surgeon. I reviewed his operative reports and he did everything humanly possible to preserve the patients lower extremities. I see no indication that there was any deviation from standard protocol in the graft manufacturing process to account for the pseudoaneurysms. " the patient had "multiple procedures in very difficult circumstances, so it is impossible to know the etiology of the pseudoaneurysm. " 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". No confirmed complaint trend was identified related to pseudoanurysm. All product quality and clinical issues will continue to be monitored within artegraft, inc. Quality systems, quality assurance trending.
Patient Sequence No: 1, Text Type: N, H10
[78863458]
A vascular surgeon notified artegraft, inc. Vp of sales during a medical conference that he had 2 patients having a description of "the ligature broke off of the side branches which resulted in aneurysm formation in the graft". Follow-up information was provided. This report is specific for patient 1 of 2 (a separate report mdr 2247686-2017-0006 will be submitted for patient 2). On (b)(6) 2017 the patient had a thrombectomy and patch angioplasty of the left popliteal artery. Viabahn (w. L. Gore) stents were placed in the left popliteal artery. Left popliteal artery tpa infusion on (b)(6) 2017 the vascular surgeon implanted an artegraft (collagen vascular graft) lot 16k249-043 in the patient's left distal superficial femoral artery to posterior tibial artery. On (b)(6) 2017, left lower extremity graft thrombectomy. 6 cm pseudoaneurysm of the left sfa to below knee popliteal bypass autograft with no pus. Intraoperative gram stain negative. The surgeon removed the aneurysmal section of the artegraft (lot 16k249-043) and bypass was completed using rifampin-soaked 7 mm ringed ptfe graft, placed interposition from the proximal and distal end of the autograft in end-to-end fashion. The patient tolerated the procedure well. On (b)(6) 2017, exploration of the left femoral popliteal graft, excision of infected distal sfa to the posterior tibial artery graft to include autograft and an interposition ptfe graft, excision of infected left distal popliteal artery patch, hemostasis of pseudoaneurysm, for the left popliteal artery, debridement of the patient's left leg. The patient reportedly has an extensive medical history. The subject graft was not returned to artegraft, inc. For evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2017-00005 |
| MDR Report Key | 6681454 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-06-30 |
| Date of Report | 2017-06-01 |
| Date of Event | 2017-04-21 |
| Date Mfgr Received | 2017-06-01 |
| Date Added to Maude | 2017-06-30 |
| 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 | 2017-06-30 |
| Model Number | AG750 |
| Catalog Number | AG750 |
| Lot Number | 16K249-043 |
| Device Expiration Date | 2019-10-31 |
| 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 | 2017-06-30 |