MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175208P0
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not accessible for testing as it remained implanted in the patient.A review of the complaint device history records, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests, including a 100% visual inspection.Specifically, no anomaly was evidenced in the textile records.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.The conducted investigation suggests that the product was not defective at the time of manufacturing.Due to their intrinsic weaving pattern, woven grafts are prone to fraying when cut with scissors.As indicated in the product instructions for use, a low-temperature disposable cautery should be used to minimize fraying when cutting this graft.Device not returned to manufacturer.
Event or Problem Description
During an aortic dissection procedure, when the surgeon cut the graft with scissors, the graft frayed.A picture of the graft was provided by the user, showing a clearly visible strand at the cutting site.

• Brand Name: HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 8707776
• Report Number: 1640201-2019-00034
• Device Sequence Number: 2387356
• Product Code: MAL
• UDI-Device Identifier: 00384401018148
• UDI-Public: 00384401018148
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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: No Information
• Device Expiration Date: 10/31/2023
• Device Model Number: M00202175208P0
• Device Catalogue Number: M00202175208P0
• Device Lot Number: 18L14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1