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

Model Number IGW0032-30

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Event Description

It was reported that during a surgery, coagulation can not be achieve despite the administration of protamine on graft.Intensive bleeding from the inside to the outside of the tubular graft was observed.The patient died post op day 1, however the surgeon indicated that the death of the patient is not related to the device.

Manufacturer Narrative

(b)(4).A remaining fragment of the involved device was returned for examination and it was sent to an external and independent laboratory.The objective of the study was to evaluate the presence of any structural abnormality visible on the external side of the returned graft and to evaluate the presence of collagen material.The analysis consisted of a macroscopic observation of the fragment and a scanning electron microscopy (sem).The sem analysis pointed out an abundant infiltration of collagen material with no obvious abnormality such as tears, loss of textile cohesion, holes and signs of cut.The sem analysis corroborated the macroscopic analysis.No conclusion can be drawn.However, the conducted investigation and testing performed would tend to indicate that the product was not defective.

• Brand Name: INTERGARD WOVEN
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7334073
• MDR Text Key: 102218693
• Report Number: 1640201-2018-00007
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000280
• UDI-Public: 00384401000280
• Combination Product (y/n): N
• PMA/PMN Number: K984294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

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
• Device Operator: No Information
• Device Expiration Date: 04/30/2021
• Device Model Number: IGW0032-30
• Device Catalogue Number: IGW0032-30
• Device Lot Number: 16E26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 03/28/2018
• Supplement Dates FDA Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR