MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED; VASCULAR POLYESTER GRAFT

Model Number HGK1809

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device is not accessible for testing as it remained implanted in the patient.A review of the complaint device history records is ongoing, results are pending.One retention sample from same lot and coated on the same period 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).The review of post-marketing historical data indicated that no other similar complaint was reported for the same product family and the same lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

After anastomosis of proximal and distal ends, clinician reported blood weeping through body of the graft once the clamps were removed.Two cases were reported together by same clinician (see manufacturer report 1640201-2019-00027 for other case).Surgeon allowed the blood to weep through then clamp for a few minutes to allow the blood to coagulate to graft wall then proceeded with rest of surgery.No indication of actual or potential harm of patient.

Manufacturer Narrative

(3331/213) 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.Moreover, the review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications (< 5 ml/cm²/min).(67) no conclusion can be drawn since the product remained implanted.However, the conducted investigation and testing performed suggest 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.

• Brand Name: HEMAGARD KNITTED
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8578403
• MDR Text Key: 143985832
• Report Number: 1640201-2019-00028
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014393
• UDI-Public: 00384401014393
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2019
• Device Model Number: HGK1809
• Device Catalogue Number: HGK1809
• Device Lot Number: 14E29
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR