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

Model Number IGK1608

Device Problem Nonstandard Device (1420)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/29/2023

Event Type  Injury  

Event Description

It was reported to intervascular that the limb of graft was porous.A piece of the limb was used to do a femoral-to-femoral bypass.After 1st anastomosis, graft was pouring out blood through material of graft.Complaint # (b)(4).

Manufacturer Narrative

(10/3233) remaining fragment of the device is available.However, it was not confirmed if the piece of the graft (limb) used during the surgery is still implanted in the patient.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 22m22.(3331/3233) the device history records is ongoing.Results are pending (11/3233) one retention sample from same sterilization lot number with the same product reference was selected based on the same coating parameters as the involved device.Visual inspection and waterpermeability testing will be performed.(4111/3233) additional information was requested to the initial reporter in order to clarify the reported event, complementary information is pending.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint #(b)(4).

Manufacturer Narrative

(10/3233) the remaining fragment of the involved device was received and sent to an external and independent laboratory for examination.The investigation is ongoing.(3331/213) the device history records review concluded that no deviation was identified in relation with the reported event.(4111/3233) further information has been requested to the initial reporter in order to clarify the reported event.Responses are pending.(11/213) one retention sample from the same sterilization lot was selected based on the same fabric type (knitted) and the same coating date and parameters as the involved device.A water permeability testing was performed on the retention sample.The test result is within specification.(11) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

Complaint # (b)(4).

Manufacturer Narrative

(10/3233) the main body and the two limbs fragments of the product were returned for inspection to an external and independent laboratory for examination.A macroscopic analysis of the fragments was carried out, and the results revealed no degradation on the fabric structure.Further microscopic analysis is being performed, results are pending.(11) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.

Manufacturer Narrative

(10/213) a macroscopic and microscopic analysis of the fragments of the involved product after cleaning biological tissues was carried out by an external and independent laboratory.Their conclusions are as follows: "macroscopic analysis of the prosthesis did not reveal any degradations of the textile structure.No small microholes were observed during the microscopic analysis.But, there are loosening of the textile mesh." the results of laboratory analysis were reviewed by the textile manager with regard to the textile loosening, who concluded that no visible degradation, such as fiber tearing, missing wires, or holes, that could explain a loss of performance, was observed.Moreover, it was highlighted that intergard/ hemagard knitted prostheses are composed of two layers, one knitted and one made using the reverse lock-knit technique.(11) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

Complaint #(b)(4).

Manufacturer Narrative

(4112/213) the case and its investigation have been reviewed by the medical affairs department whose assessment is below: "this complaint refers to an event of bleeding that occurred during a femoral-to-femoral artery bypass.The information provided regarding this complaint was limited describing only that there was diffuse bleeding after completion of the first anastomosis.Multiple attempts to gather further information were unsuccessful.The graft in question is a igk1608 - hemagard knitted bifurcated graft of which one limb was used.The limb that bled was returned to intervascular together with the rest of the bifurcated graft.The graft was sent to an independent laboratory for analysis.The results showed no microholes or degradation of the textile structure.However, there was a loosening of the textile mesh in the area shown in the photo below, adjacent to the anastomosis.The water permeability test of the retention samples was within specifications.Bleeding may occur due damage of the collagen coating caused by handling of the device or use of traumatic vascular clamps.Due to the lack of information provided a comprehensive assessment of this event cannot be completed." (4110/213) occurrence of bleeding events is calculated and reviewed monthly during quality meeting.In (b)(6) 2023, the bleeding rate on intergard/hemagard grafts was below the maximum anticipated by the product risk assessment.(67) based on the investigation findings and the medical review, no conclusion can be drawn on the exact origin of the adverse event reported due to the lack of information provided about the surgical intervention and the patient's conditions.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.The examination results of returned fragments did not reveal any degradation of the textile structure, that could explain a loss of performance.Moreover, the medical affairs department underlines that bleeding may occur due damage of the collagen coating caused by handling of the device or use of traumatic vascular clamps.(22) to be noted that bleeding is an undesirable side-effect as indicated in the product instructions for use.

Event Description

Complaint # (b)(4).

• Brand Name: INTERGARD 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: 17442408
• MDR Text Key: 320217554
• Report Number: 2242352-2023-00648
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000488
• UDI-Public: (01)00384401000488
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/11/2023

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: Health Professional
• Device Model Number: IGK1608
• Device Catalogue Number: IGK1608
• Device Lot Number: 22M22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2023
• Distributor Facility Aware Date: 12/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 07/26/2023; 09/15/2023; 11/06/2023; 12/04/2023
• Supplement Dates FDA Received: 08/22/2023; 10/04/2023; 12/01/2023; 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose