MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-11-08 for AXOGUARD NERVE CONNECTOR AND PROTECTOR AG1040 manufactured by Cook Biotech.
[91332570]
A review of the device lot history records was performed. Based on that review, the non-conformances could not have contributed to the reported occurrence. All thirteen (13) devices released from the lot were manufactured to specifications. A review of the cbi complaint database did not reveal any additional complaints involving the reported device lot number. A review of the ifu indicated that? Infection, allergic reaction, and acute or chronic inflammation (initial application of surgical graft materials may be associated with transient, mild, localized inflammation)? Are potential complications. The ifu also notes that if these? Conditions occur and cannot be resolved, careful removal of the device should be considered. " a review of the pathology report was performed by cook research incorporated? S veterinary pathologist. The review indicated that the tissue changes were compatible with healing changes at four (4) weeks post-op. The acute inflammation in the flexor tendon and the fibrinoid necrosis and acute neutrophilic inflammation in the nerve wrap suggested a post-op bacterial infection. The chronic inflammation and palisading granulomatous inflammation could indicate the infection was present for at least 2 weeks. However, to a small degree, chronic inflammation is normal part of tissue remodeling with sis. The root cause, of the patient? S post-op experience, was likely related to a post-operative bacterial infection. The axoguard nerve protector, as provided to the user, unlikely caused or contributed to the infection. Cook biotech incorporated has a validated sterilization cycle with a sterility assurance level of (sal) 10^-6. The validated sterility cycle and all parameters of all devices are verified prior to release for distribution. Possible contributing factors, to the patient? S wound infection, could include, but is not limited to a nosocomial infection, contamination during the surgical procedure, or inadequate post-op care of the surgical wound.
Patient Sequence No: 1, Text Type: N, H10
[91332571]
On (b)(6) 2017, dr. (b)(6) placed an axogen nerve protector in a left wrist for a compartmental carpal tunnel revision. This was for treatment of recurrent carpal tunnel syndrome. The device was hydrated for one (1) minute. Wound closure was one (1) layer with 4-0 suture. The patient developed intense flexor synovitis at four (4) weeks post device implantation. On (b)(6) 2017, the patient underwent a flexor synovectomy and the nerve protector was explanted. The explanted device was sent for cultures and pathology. At the time the feedback was reported, the surgeon was uncertain if the device caused or contributed to the need for reoperation on (b)(6) 2017. The pathology results for the left wrist synovium of the left flexor tendon showed mild acute and chronic inflammation and marked reactive changes. The explant showed synovial tissue with reactive changes including synovial hyperplasia, hypervascularity, and mild fibrosis. In addition, mild focal acute inflammation and scattered small lymphoid aggregates of chronic inflammation were seen. The pathology results for the left wrist nerve wrap showed marked acute inflammation and marked reactive changes. The explant showed fibrovascular tissue with fibrinoid necrosis of one surface and associated marked acute inflammation with numerous neutrophils. Focal areas of palisading granulomatous reaction were also seen. The underlying tissue showed moderate-to-marked chronic inflammation with scattered lymphoid aggregates. Based on the pathology results, dr. (b)(6) reported that surgical infection was not believed to be the cause of the occurrence, rather a tissue reaction to the implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2017-00009 |
| MDR Report Key | 7009311 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-07 |
| Date of Event | 2017-10-13 |
| Date Mfgr Received | 2017-10-13 |
| Device Manufacturer Date | 2016-09-30 |
| Date Added to Maude | 2017-11-08 |
| 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 | MR. PERRY GUINN |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal | 47906 |
| Manufacturer Phone | 7654973355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXOGUARD NERVE CONNECTOR AND PROTECTOR |
| Generic Name | NERVE PROTECTOR |
| Product Code | JXI |
| Date Received | 2017-11-08 |
| Catalog Number | AG1040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK BIOTECH |
| Manufacturer Address | 1425 INNOVATION PLACE WEST LAFAYETTE IN 47906 US 47906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-08 |