MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR; VASCULAR POLYESTER GRAFT

Model Number	M002020954080
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not accessible for testing as it remained implanted in 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.These tests include a 100% visual inspection of the graft.Specifically, the review of the collagen coating records evidenced no anomaly.A retention sample from same lot and coated on the same day and under the same conditions as the involved device was identified.A visual inspection by the qa department will be performed.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Two vascular grafts were sutured together and were used on the same patient (see manufacturer report 1640201-2019-00012 for the other involved device).When suturing the grafts to be implanted, it was noticed that the collagen coating was crumbling like bread crumbs.The surgeon wet the grafts with sterile saline and no more crumbling was noticed.The grafts were implanted in the abdominal area with no other signs of issues or complications.
Additional Manufacturer Narrative
(11/213) one retention sample from same lot and coated on the same day and under the same conditions as the involved device was visually inspected by our qa supervisor.No anomaly was found.(4315) no conclusion can be drawn since both involved products remained implanted.However, the conducted investigation suggests that the devices were not defective at the time of manufacturing.

• Brand Name: HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8382219
• Report Number: 1640201-2019-00013
• Device Sequence Number: 2326547
• Product Code: MAL
• UDI-Device Identifier: 00384401017486
• UDI-Public: 00384401017486
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K954848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: 05/31/2023
• Device Model Number: M002020954080
• Device Catalogue Number: M002020954080
• Device Lot Number: 18F13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1