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 2017-05-17 for ARTEGRAFT manufactured by Artegraft,inc..
[75331314]
The complaint artegraft (collagen vascular graft) was returned to artegraft, inc. For evaluation. Visual evaluation of the returned graft verified that the graft had been cut into 3 segments and a black suture was visible on one of the smaller graft segment ends. The customer's allegation of leaking graft pre-implant and thrombosed/"white clot" during the implant procedure were not able to be confirmed. A review of the production batch records was not able to be conducted as graft lot and product code were not provided (multiple attempts were made to retrieve the information). Possible root causes for the leaking graft pre-implant may be that a ligation suture on the graft tributary loosened or too much force may have applied during the pre-implant pressure test. No additional information is available regarding the tools/methods utilized by the customer for pressure testing for this incident. As this is a known issue, artegraft, inc. Instructions for use include instructions for pressure testing each graft prior to implant. Capa was previously initiated to investigate similar occurrences involving graft wall leaks pre-implant. Additional quarterly analysis of the grafts was implemented for post-sterilization data and trending. No complaint trend was identified related to thrombosis. Possible root cause for the thrombosis and "white clot" was stated by the implanting surgeon that she did not believe the graft caused any of the issues but rather the patient's hypotension with the use of pressors without the use of heparin. With the second artegraft, without pressors and with heparin, the implant was successful. Thrombosis is a known adverse reaction and is discussed in the 'warnings' section of the artegraft instructions for use, ls 012 rev. M. The complaint issues will continue to be monitored within artegraft, inc. Quality systems, quality assurance trending. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[75331315]
Artegraft inc. Received an email communication that an artegraft (collagen vascular graft) was implanted and then explanted. In follow-up conversations with the implanting surgeon from the hospital it was explained that "when i first flushed the graft, there was a small leak at one end. I opted to trim this section and use the remainder of the graft. It was a distal brachial artery to proximal brachial vein graft. Initially, the graft had a good thrill. I opted to band the graft due to augmentation of distal signals. By the time, i completed the banding, the graft was completely thrombosed. Other factors at play were hypotension requiring pressors, and heparin was not given prior to the anastomosis. Of note, the entire graft was filled with "white" clot. Once i cleared clot from the artery, gave heparin and ask anesthesia to avoid pressors, we created a new access with a new artegraft. This was successful. " artegraft scientific advisor, spoke with the implanting surgeon to discuss the details related to this incident. The surgeon stated that she did not believe the graft caused any of the issues but rather the patient's hypotension with the use of pressors without the use of heparin. With the second artegraft, without pressors and with heparin, the implant was successful. The complaint graft was returned to artegraft inc for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2017-00004 |
| MDR Report Key | 6571928 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-05-17 |
| Date of Report | 2017-04-17 |
| Date of Event | 2017-04-13 |
| Date Mfgr Received | 2017-04-17 |
| Date Added to Maude | 2017-05-17 |
| 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 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 | 2017-05-17 |
| Returned To Mfg | 2017-05-04 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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. Congenital Not Applicablenomaly; 2. Required No Informationntervention | 2017-05-17 |