MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-09-07 for ARTEGRAFT AG750 manufactured by Artegraft, Inc.
[85158574]
The artegraft (collagen vascular graft) was not returned to artegraft, inc. For evaluation as it remains implanted. A review of the production batch record was performed; no anomalies were identified. All grafts released from product batch 16l298 passed all of the requirements including pressure testing and sterility 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 "it is my clinical impression that the presence of a klebsiella (esbl) is the reason why the graft deteriorated. A 5 cm defect is not consistent with a tributary failure. There appeared to be a tunnel infection. The anastomosis was intact. When the patient was seen in the office, there was no mention of a pulsatile mass in the thigh. " artegraft, inc. Ifu dosage and administration section provides instructions for aseptically remove the artegraft from its container. Additionally, the adverse reaction section states "disruption of anastomoses, especially in the presence of infection, has been observed and, in a few cases, transient low grade fever, the etiology, of which has not been obvious, has been experienced. " 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.
Patient Sequence No: 1, Text Type: N, H10
[85158575]
Artegraft, inc. Received an email from an approved distribution representative regarding a possible "ruptured" artegraft (collagen vascular graft). The representative had received a phone call from the charge rn at (b)(6) on behalf of the surgeon (dr. (b)(6) to inform of an issue that occurred with a patient admitted through the er with excessive bleeding from a groin incision. The surgeon gained control of the bleeding and identified a 5cm oval shaped "defect" on the artegraft, approximately 4cm from the arterial anastomoses. The surgeon said it appeared that the graft had "ruptured" in this one area, and that the graft looked like it had "blown out". After the surgeon patched the site, he did a culture of the groin area and noted an infection was present at the time. Follow-up details. The graft was implanted on (b)(6) 2017 for a fem-pop bypass. The patient was seen in the surgeon's office on (b)(6) 2017, clear oozing was identified from the groin incision, culture was done at this time but the results were not returned by the time patient went to er the patient was admitted to er on (b)(6) 2017 for the issue of possible graft rupture; a 5cm "defect" was identified at this time. Dr. (b)(6) patched the artegraft. The patient was swabbed again at the time of surgery on (b)(6) 2017. The swab was positive for klebsiella (esbl) infection. The patient was in isolation in the hospital after surgery and the antibiotics were prescribed to treat the current infection as well as prevent infection in the future. The patient was discharged from the hospital on (b)(6) 2017. Incision and surgery site appeared normal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2017-00008 |
| MDR Report Key | 6849392 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-09-07 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-08-05 |
| Date Mfgr Received | 2017-08-09 |
| Device Manufacturer Date | 2017-01-12 |
| Date Added to Maude | 2017-09-07 |
| 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 | 2017-09-07 |
| Model Number | AG750 |
| Catalog Number | AG750 |
| Lot Number | 16L298-002 |
| Device Expiration Date | 2019-12-31 |
| 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. Life Threatening; 2. Required No Informationntervention | 2017-09-07 |