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 2018-02-07 for ARTEGRAFT AG636 manufactured by Artegraft, Inc.
[99211318]
Device 2 of 2; refer to mdr-2247686-2018-00002 for device 1 of 2. The two artegraft (collagen vascular grafts) were not returned to artegraft, inc. For evaluation as they remain implanted. A review of the production batch record was performed; no anomalies were identified. All grafts released from product batch 16j215 passed all of the requirements including pressure testing and sterility testing prior to final release to finished goods. In follow-up conversations between the distributor representative and the surgeons' staff at (b)(6) hospital, it was stated that the tamper evident seal was in place on the box , the shrink wrap was present on the tube prior to use, and the graft was prepared per the ifu prior to use. Artegraft, inc. Mailed a certified letter to (b)(6) hospital requesting additional information related to the events. To date, no additional information was provided. Artegraft, inc. Chief medical officer (qualification: m. D. , f. A. C. S. ) reviewed the case details and stated that "in the event that a wound infection occurs in the area of the artegraft, increased surveillance must be undertaken. Graft is collagen. Collagen may break down in the presence of pseudomonas, mrsa, e. Coli. " artegraft, inc. Ifu dosage and administration section provides instructions for aseptically removing 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
[99211319]
Artegraft, inc. Received an email from an approved distributor representative on behalf of a vascular surgeon (dr. (b)(6)) stating that he recently had 2 patients that acquired infections roughly 2 weeks post-op artegraft (collagen vascular graft) implant for peripheral use. This file will capture patient 1 of 2. On (b)(6) 2017 the patient had femorodistal bypass surgery with two 5mm artegrafts. The bypass "went down" and the patient ended up in another facility before coming back to dr. (b)(6). When the patient presented to him roughly 2 weeks post-op, she had pseudomonas. The surgeon mentioned that the graft "dissolved" in a portion where it was infected and had a "big hole" in it. The patient reportedly expired and it was stated that it was "not due to the artegraft".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2018-00003 |
| MDR Report Key | 7247266 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-02-07 |
| Date of Report | 2018-04-20 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-03-21 |
| Device Manufacturer Date | 2016-11-07 |
| Date Added to Maude | 2018-02-07 |
| 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 | 2018-02-07 |
| Model Number | AG636 |
| Catalog Number | AG636 |
| Lot Number | 16J215-024 |
| Device Expiration Date | 2019-09-30 |
| Operator | PHYSICIAN |
| 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. Life Threatening; 2. Required No Informationntervention | 2018-02-07 |