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

Model Number HGK1407

Device Problem Material Too Soft/Flexible (4007)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device involved in the adverse event remained implanted.

Event Description

It was reported to intervascular that the implanted graft was a substitution for "#(b)(4)".They used one [graft] on (b)(6) 2022 and the week before, and stated "the graft was very soft and flimsy and kept kinking in the tunnel.Leading to 3 repeated attempts and case bleeding.It is not a safe and acceptable alternative".Complaint #(b)(4).

Manufacturer Narrative

Corrected data : block b1"product problem" was updated to "product problem/ adverse event" due to the lack of information, the worst case scenario was considered.Block b2 was completed as required.(4111) several attempts to contact the customer was performed by the medical department.No response could be obtained.(4112/213) the case was reviewed by the corporate medical department whose assessment is below: "the complaint received states that a hemagard 14x7 bifurcated graft was implanted in a patient.It appears that the hemagard graft is a substitute for their typically used graft, however the brand of graft is unknown at this time.The customer states that the hemagard graft is soft, flimsy and kinks easily, causing bleeding after repeated attempts to implant.No other information is known at this time.Retention product from the same lot, coated on the same day was visually inspected and underwent water permeability testing and revealed that the product is within specifications.A request for additional details of the procedure has been sent back to the customer, and these comments and summary will be updated when they are received.Attempts to request further information on this complaint were made on dec 14, 2022; dec 15, 2022; dec 22, 2022; and jan 5, 2023.There was no response.Due to the lack of information available we were unable to arrive at a conclusion.Should additional information be obtained in the future, this medical assessment will be updated to reflect those findings." (4315) no conclusion can be drawn on the exact origin of the adverse event since the product remained implanted.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.

Event Description

Complaint #(b)(4).

• Brand Name: HEMAGARD KNITTED BIFURCATED
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 15958410
• MDR Text Key: 305243205
• Report Number: 1640201-2022-00037
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014386
• UDI-Public: (01)00384401014386
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HGK1407
• Device Catalogue Number: HGK1407
• Device Lot Number: 22A20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention