MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR; VASCULAR POLYESTER GRAFT

Model Number	M00202166168P0
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
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.These tests include a 100% visual inspection of the graft using a backlit table to reveal the presence of any holes in the textile structure.Moreover, the review of the water permeability testing records of a product coated on the same day as the complaint device indicated values well within product specifications.One retention sample from same product family, same lot and coated on the same day and under the same conditions as the involved device was visually inspected by a qc operator under real working conditions.No anomaly was found.This retention sample also underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.No conclusion can be drawn since the product remained implanted.However, 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
During surgery, a hole was identified at the crotch of the bifurcated graft.The surgeon sewed the graft hole in order to stop the bleeding.Patient was endangered but not injured.
Additional Manufacturer Narrative
The conclusion has been amended: (25) the outcome of the investigation indicates that this is an isolated case, probably due to insufficient sewing at the crotch of the graft.It has been decided to increase awareness of all sewing operators concerning the risk of insufficient sewing.

• Brand Name: HEMASHIELD PLATINUM WOVEN 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: 8142266
• Report Number: 1640201-2018-00028
• Device Sequence Number: 195156
• Product Code: MAL
• UDI-Device Identifier: 00384401018452
• UDI-Public: 00384401018452
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/30/2022
• Device Model Number: M00202166168P0
• Device Catalogue Number: M00202166168P0
• Device Lot Number: 17M20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention