MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN; VASCULAR POLYESTER GRAFT

Model Number	IGW0028-30
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the complaint device history records is ongoing, results are pending.The involved device as received was visually inspected and collagen peel-off coming from the graft coating itself was confirmed.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
The interior lumen of the vascular graft had some type of debris in it upon opening the graft.
Additional Manufacturer Narrative
(10/3331/213) 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.(11/213) a retention sample from same lot and coated on the same day and under same conditions as the involved device was visually inspected by our qa supervisor.No collagen peel-off was found.This retention sample also underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).(4109/213) the review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.(4315) no conclusion can be drawn.The conducted investigation would tend to indicate that the product was meeting its specification at the time of manufacture.Please note that, as per instruction for use, care should be taken when handling the graft to avoid damaging the collagen coating.

• Brand Name: INTERGARD WOVEN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7578307
• Report Number: 1640201-2018-00016
• Device Sequence Number: 13877586
• Product Code: DSY
• UDI-Device Identifier: 00384401000242
• UDI-Public: 00384401000242
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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: 07/31/2022
• Device Model Number: IGW0028-30
• Device Catalogue Number: IGW0028-30
• Device Lot Number: 17H31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1