MAUDE Adverse Event Report: ARTEGRAFT, INC. ARTEGRAFT; COLLAGEN VASCULAR GRAFT

Model Number AG640

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint artegraft (collagen vascular graft) lot 19l318-027 was not returned to artegraft, inc.For evaluation as it was repaired, trimmed, and implanted.A review of the production batch record was performed; no anomalies were identified.All grafts released from product batch 19l318 passed all of the requirements including pressure testing and wall thickness prior to final release to finished goods.The customer's allegation of a graft "hole" pre-implant was visually verified via photograph.A review of the photographs indicates a cut/slit in the graft wall.As 100% of grafts manufactured are pressure tested and then visually inspected by two technicians prior to release, it is highly unlikely that a defect of this nature would have passed the inspection release process.As this is a known possible issue, artegraft, inc.Instructions for use include instructions for pressure testing each graft prior to implant.The preparation for implant section states, "artegraft is manometry pressure tested and quality inspected.Before implanting, occlude one end of graft and pressure test with syringe filled with saline solution." a likely possible root cause is that the graft was mistakenly damaged at the customer site during the preimplant preparation steps.Additional follow-up information was requested including current patient status, patient information, and additional details about when and how the issue was discovered.To date, additional requested information has not been provided.To date, no additional complaints were reported from this product batch, 19l318.The complaint issue 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.

Event Description

Artegraft inc.Received an email communication from an authorized distributor that an artegraft (collagen vascular graft) was identified prior to implant as having a "hole".It was also noted that the graft "seemed thinner than normal".The surgeon was able to repair the graft hole with suture but subsequently trimmed, and disposed of that portion of the graft; the remaining graft length (lot: 19l318-027) was successfully implanted.No patient adverse events were reported.

Manufacturer Narrative

Follow-up 001.Section b3: date of the event was corrected from (b)(6) 2020 to (b)(6) 2020.Section g4: additional information was received on 05/04/2020.Current patient status was reported as stable.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 north center drive; north brunswick, nj
• MDR Report Key: 9998316
• MDR Text Key: 226251395
• Report Number: 2247686-2020-00002
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00316837000244
• UDI-Public: (01)00316837000244(17)221130(10)19L318-027
• Combination Product (y/n): N
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: AG640
• Device Catalogue Number: AG640
• Device Lot Number: 19L318-027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 90