MAUDE Adverse Event Report: INTERVASCULAR SAS HEMABRIDGE WOVEN GRAFT; VASCULAR GRAFT PROSTHESIS

Model Number HEW2610BRIDGE

Device Problem Device Packaging Compromised (2916)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2015

Event Type  malfunction  

Event Description

It was reported by the dealer that the product packaging components were stained: the external carton box and the external /internal lids.The product was returned for evaluation.

Manufacturer Narrative

(10/3317/213) a review of the device history records indicated that the graft was processed and inspected according to procedures and no anomaly was found.(10/38/3275/3233) the returned sample was evaluated by the qa/qc manager.The nature of the stain is suspected to be glycerol (present in the collagen coating material).Samples of the returned packaging components (stained inner lid, outer lid and carton box) will been sent to an outside laboratory in order to identify the exact nature of the stains.(3233/11) the investigation is still in progress.No conclusion can be drawn at the time of this report.

Manufacturer Narrative

Samples of the returned packaging components (stained inner lid, outer lid and carton box) were analyzed in an outside laboratory by gc-ms.A sample of the glycerol used in production was also provided for comparison.The laboratory confirmed the stains to be of glycerol nature.Product as received do not comply with its specification.Capa system initiated to identify the root cause.The investigation is still in progress.No conclusion can be drawn at the time of this report.

Manufacturer Narrative

(331/4309) the performed investigation concluded that the complaint product might have been exposed to inadequate storage conditions.It is indeed anticipated that, when exposed to a high temperature, some of the glycerol present in the collagen coating can migrate out of the graft and get absorbed by the tyvek lids and carton box.As no storage conditions record is available at the taiwanese distributor warehouse, all products having been stored at this location are considered as potentially affected.In addition, it is deemed that the condition of the stained products is not impacting their performances, beyond the cosmetic aspect, at baseline.However, no information is available regarding the stability of products having been exposed to such storage conditions.Therefore, as a measure of precaution, intervascular has decided to withdraw from the market all unused products potentially affected, all located in taiwan.Additional narrative and corrected data: this mdr is one of a series of four resubmissions.Indeed, following the fda's email dated june 24th, 2020 informing us on an issue about the initial mdr #16402201-2016-00008 which was not received, and the confirmation of an error of submission environment on july 6th, 2020, an internal non-conformity report was initiated on july 6th, 2020 in order to investigate the root cause of the issue and take appropriate corrective actions.In this context, the mdr # 16402201-2016-00008 was resent on july 10th, 2020 and three additional mdr's were identified as affected by the same discrepancy (original submission in the test environment instead of the production environment): initial mdr # 1640201-2016-00007.Supplemental report 1 for mdr # 16402201-2016-00004.Supplemental report 2 for mdr # 16402201-2015-00024.It is why we are resubmitting today the present report with the original data.Please note that some original data have been corrected in this resubmission: contact information in g 1-2 (update).Conclusion code in h6 and h10 (use of code 4309 instead of 21 which seems more in coherency today with the investigation conclusion).And h10 was supplemented to add details concerning the resubmission.We apologize for this issue.

• Brand Name: HEMABRIDGE WOVEN GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 4902272
• MDR Text Key: 6538044
• Report Number: 1640201-2015-00024
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,distributor
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2020

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
• Device Operator: Other
• Device Expiration Date: 09/30/2019
• Device Model Number: HEW2610BRIDGE
• Device Catalogue Number: HEW2610BRIDGE
• Device Lot Number: 14K30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2015
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 07/09/2015
• Supplement Dates Manufacturer Received: Not provided; 01/30/2016
• Supplement Dates FDA Received: 07/24/2015; 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1