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

Model Number	M00202175928P0
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of historical data indicated that no other similar complaints was reported for the same sterilization lot.The device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.It was reported that the product is available for investigation, it should be returned to intervascular for examination.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
(b)(4).When the customer opened the product, he found yellow blot on the inner package of the graft.It occurred before the surgery.As we know, the surgery did not delay.
Additional Manufacturer Narrative
Corrected data: block b5: the event description has been changed following clarification obtained during the investigation.Additional narrative: (10/170) the involved product was returned to intervascular and was visually inspected by our quality assurance (qa) supervisor.The conclusion is as follows: "the discrepancy is confirmed, the prosthesis has yellow blots.These blots are similar to collagen excesses.This defect is an aesthetic defect.I can confirm that as it stands the product should have been declared non-compliant." (143) the outcome of the investigation would tend to indicate that the issue is related to a presence of collagen excesses, which should have been rejected during the 100% visual inspection.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.
Event or Problem Description
See initial mfr report #1640201-2020-00003.Complaint # (b)(4) corrected data: following clarification, the event is described as follows: when the customer opened the product, they found there was yellow blot on surface of the graft.

• Brand Name: HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VACULAR GRAFT
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9680453
• Report Number: 1640201-2020-00003
• Device Sequence Number: 3445806
• Product Code: MAL
• UDI-Device Identifier: 00384401018650
• UDI-Public: 00384401018650
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2020

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: 07/31/2022
• Device Model Number: M00202175928P0
• Device Catalogue Number: M00202175928P0
• Device Lot Number: 17H02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1