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

Model Number HGK0008-100

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 05/09/2019

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.A retention sample from same lot as the involved device was identified.It will undergo water permeability testing.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.Not returned to manufacturer.

Event Description

During an aorto-femoral surgery, a disproportionate bleeding occurred when declamping.A slight pressure was applied on the graft for a few minutes until bleeding stopped.

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.Specifically, no anomaly was evidenced in the collagen coating records.Moreover, the review of the water permeability testing records of products coated on the same period/day as the complaint device indicated values well within product specifications (< 5 ml/cm²/min).(11/213) one retention sample from same lot and 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.

• Brand Name: HEMAGARD KNITTED
• 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: 8747342
• MDR Text Key: 150856937
• Report Number: 1640201-2019-00035
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014126
• UDI-Public: 00384401014126
• 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: 07/30/2019

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: 09/30/2023
• Device Model Number: HGK0008-100
• Device Catalogue Number: HGK0008-100
• Device Lot Number: 18K18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 07/05/2019
• Supplement Dates FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other