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

Model Number	AG640
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 north center drive; north brunswick, nj
• MDR Report Key: 9998316
• Report Number: 2247686-2020-00002
• Device Sequence Number: 3896128
• Product Code: LXA
• UDI-Device Identifier: 00316837000244
• UDI-Public: (01)00316837000244(17)221130(10)19L318-027
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N16837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 90