MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-05-26 for AXOGUARD NERVE CONNECTOR AND PROTECTOR AG0220 manufactured by Cook Biotech.
[46021611]
Date of event not provided by the complainant. Implant date not provided by the complainant. A review of the device history records indicated the device was manufactured to specifications and that 20 devices were released from lb81922. A review of the cbi complaint database revealed no other complaints involving lb881922. The ifu notes that the "device has been sterilized with ethylene oxide" and is "supplied sterile. " a review of the ifu indicated that "the axoguard nerve protector is indicated for the repair of peripheral nerve injuries where there is no gap. " infection is noted as one of the possible complications that "can occur with any nerve repair surgical procedure. " additionally, the potential complications note that "if any of the following conditions occur and cannot be resolved, careful removal of the device should be considered: infection, allergic reaction, and acute or chronic inflammation (initial application of surgical graft materials may be associated with transient, mild, localized inflammation. " a post op infection is a known inherent risk of any surgical procedure. The root cause of the reported infection is inconclusive. However, it is valid to point out that the patient had a history of a (b)(6) infection at some time point prior to the implantation of the axoguard nerve protector. Also, while the redness at the surgical site improved with iv antibiotics, no wound culture was obtained to confirm an infection and no lab work results were reported to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[46021612]
Dr. (b)(6) implanted a 50 mm avance nerve graft (human nerve allograft) and an ag0220 axoguard nerve connector for the repair of a gap in the radial sensory nerve in the distal forearm area. The axoguard nerve connector was cut in half for both coaptation sites. The axogen sales manager was notified that the patient developed an infection, in the area of the graft, and was hospitalized. Dr. (b)(6) reported the infection appeared to run along the graft line. The patient received antibiotics for the treatment of the infection in the hospital. The surgeon also reported that the patient had a history of (b)(6). Update: 05/11/2016 - further follow-up with the surgeon revealed that there was no noted damage to the device packaging at the time of use. Standard micro-suture was used to secure the device in place and the surgical site was closed with suture. Instrumentation used during the surgery was provided and sterilized by the hospital. There were reportedly no complications during the surgical procedure. The patient first presented with the infection within one (1) week after surgery. The infection was noted as redness at the incision site with no drainage or exudate. The patient was treated with oral antibiotics for two (2) weeks. The infection reportedly became progressively worse and the patient was admitted to the hospital for treatment with iv vancomycin (antibiotic). The redness and swelling resolved with the iv vancomycin and no debridement of the surgical site occurred. There was no wound culture obtained as there was no drainage present. The patient was in the hospital for three (3) days and at the time of discharge, the infection appeared controlled and no further treatment was prescribed. The surgeon will see the patient again in follow-up in three (3) weeks.
Patient Sequence No: 1, Text Type: D, B5
[48070963]
Date of event not provided by the complainant. Implant date not provided by the complainant. A review of the device history records indicated the device was manufactured to specifications and that 20 devices were released from lb81922. A review of the cbi complaint database revealed no other complaints involving lb881922. The ifu notes that the "device has been sterilized with ethylene oxide" and is "supplied sterile. " a review of the ifu indicated that "the axoguard nerve protector is indicated for the repair of peripheral nerve injuries where there is no gap. " infection is noted as one of the possible complications that "can occur with any nerve repair surgical procedure. " additionally, the potential complications note that "if any of the following conditions occur and cannot be resolved, careful removal of the device should be considered: infection, allergic reaction, and acute or chronic inflammation (initial application of surgical graft materials may be associated with transient, mild, localized inflammation. " a post op infection is a known inherent risk of any surgical procedure. The root cause of the reported infection is inconclusive. However, it is valid to point out that the patient had a history of a mrsa infection at some time point prior to the implantation of the axoguard nerve protector. Also, while the redness at the surgical site improved with iv antibiotics, no wound culture was obtained to confirm an infection and no lab work results were reported to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[48070964]
Dr. (b)(6) implanted a 50 mm avance nerve graft (human nerve allograft) and an ag0220 axoguard nerve connector for the repair of a gap in the radial sensory nerve in the distal forearm area. The axoguard nerve connector was cut in half for both coaptation sites. The axogen sales manager was notified that the patient developed an infection, in the area of the graft, and was hospitalized. Dr. (b)(6) reported the infection appeared to run along the graft line. The patient received antibiotics for the treatment of the infection in the hospital. The surgeon also reported that the patient had a history of (b)(6). Update: 05/11/2016 - further follow-up with the surgeon revealed that there was no noted damage to the device packaging at the time of use. Standard micro-suture was used to secure the device in place and the surgical site was closed with suture. Instrumentation used during the surgery was provided and sterilized by the hospital. There were reportedly no complications during the surgical procedure. The patient first presented with the infection within one (1) week after surgery. The infection was noted as redness at the incision site with no drainage or exudate. The patient was treated with oral antibiotics for two (2) weeks. The infection reportedly became progressively worse and the patient was admitted to the hospital for treatment with iv vancomycin (antibiotic). The redness and swelling resolved with the iv vancomycin and no debridement of the surgical site occurred. There was no wound culture obtained as there was no drainage present. The patient was in the hospital for three (3) days and at the time of discharge, the infection appeared controlled and no further treatment was prescribed. The surgeon will see the patient again in follow-up in three (3) weeks. Update #2 - an axogen representative spoke with the surgeon's nurse on 06/06/2016 and was informed that the patient had returned to regular duty at work. The patient had a fair amount of strength and feeling with the recovery. There were no further issues relating to the infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2016-00064 |
| MDR Report Key | 5682530 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-05-26 |
| Date of Report | 2016-06-20 |
| Date Mfgr Received | 2016-06-18 |
| Device Manufacturer Date | 2016-01-14 |
| Date Added to Maude | 2016-05-26 |
| 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 | 2016-05-26 |
| Catalog Number | AG0220 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2016-05-26 |