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

Model Number	IGK0008-70
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
See initial mfr report # 1640201-2019-00092.Complaint # (b)(4).

• Brand Name: INTERGARD KNITTED STRAIGHT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9490783
• Report Number: 1640201-2019-00092
• Device Sequence Number: 13973066
• Product Code: DSY
• UDI-Device Identifier: 00384401000372
• UDI-Public: 00384401000372
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other