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

Model Number	IGW0032-15
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A fragment of the involved device was returned to intervascular and was inspected by our quality assurance manager.His comments are as follows: "the product has not been returned in its entirety and it is damaged and soiled.Concerning the flexibility of the product, as it has been soiled and dried, it is not possible to carry out an analysis." 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.Specifically, no anomaly was evidenced in the textile or collagen coating records.Moreover, the tests include a 100% visual inspection of the graft.A retention sample of the same textile type and from same lot as the involved device has been identified.An examination by the quality 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
According to the surgeon, the surgery did not happen as usual.The involved graft was not flexible and was difficult to handle intraoperatively.A small sample of the graft was returned for examination.It is unknown if a portion of the graft remained implanted.Patient was neither injured nor endangered.
Event or Problem Description
It was confirmed that the graft remained implanted.
Additional Manufacturer Narrative
(11/213) the analysis of a retention sample of the same textile type and from same lot as the involved device was performed by a quality control technician.No anomaly was found.The elasticity of the product was found to be the same as what is observed in routine quality control.(67) the outcome of our investigation suggests that the graft was not defective.The case was reviewed and discussed with the r&d team.It was confirmed that our process may lead to slight difference in crimp density (crimps/cm, i.E.Stretchability of the graft), but since this is not associated to the graft performance, there is no defined product specification related to stretchability.

• 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: 8456821
• Report Number: 1640201-2019-00020
• Device Sequence Number: 3014162
• Product Code: DSY
• UDI-Device Identifier: 00384401000273
• UDI-Public: 00384401000273
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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: IGW0032-15
• Device Catalogue Number: IGW0032-15
• Device Lot Number: 18L29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1