MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD KNITTED STRAIGHT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number IGK0008-70

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

The device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.Device is not accessible for testing as it remained implanted in the patient.The review of historical data indicated that one other bleeding was reported for the same product family and same sterilization lot number.However it was a different use of the product (off label use).One retention sample coated on the same day and under the same conditions as the involved device was identified.A water permeability test will be performed.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.Device remained implanted.

Event Description

When the prosthesis was implanted (left femoro femoral bypass), it began to sweat all the way through with blood droplets.After a few minutes, there is a stop of the leak.Decision to leave the prosthesis in place.

Manufacturer Narrative

(4102/213) one retention sample coated on the same day and under the same conditions as the involved device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).(67) no conclusion can be drawn since the product remained implanted.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.(22) please note that blood leakage is a foreseeable side-effect as indicated in the instructions for use.

Event Description

See initial mfr report # 1640201-2019-00092.Complaint # (b)(4).

• Brand Name: INTERGARD KNITTED STRAIGHT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9490783
• MDR Text Key: 219770907
• Report Number: 1640201-2019-00092
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000372
• UDI-Public: 00384401000372
• Combination Product (y/n): N
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: IGK0008-70
• Device Catalogue Number: IGK0008-70
• Device Lot Number: 17A05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other