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

Model Number HGKAX0808

Device Problem Nonstandard Device (1420)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 18c15.(3331/213) the device history records review concluded that there was no non-conformance/planned deviation in relation with the event reported.(4111/3233) more information has been requested to the initial reporter in order to clarify the event.Responses are pending.(4102/3233) one retention sample from another sterilization lot number was selected based on the same coating parameter and the same fabric (knitted) as the involved device.Visual inspection and waterpermeability testing will be performed.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.4115 - device discarded.

Event Description

It was reported to intervascuclar that when the surgeon attempted to use a hemagard knitted axillo graft (hgkax0808), there was bleeding through the material of the hemagard graft.He had to use a different vascular graft to complete the surgery.Complaint #: (b)(4).

Event Description

Complaint #(b)(4).

Manufacturer Narrative

(4102/213) one retention sample from another sterilization lot number (18c22) was selected based on the same fabric type (knitted), coated at a close date and with the same coating parameters as the involved device.A visual inspection performed by the quality supervisor concluded that the product is in compliance with the specification.A water permeability testing was also 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

(4112/213) the case and its investigation have been reviewed by the medical affairs department whose assessment is below: "this complaint is regarding an intergard knitted axillo bifemoral graft.The surgery was performed on (b)(6) 2023 at (b)(6) hospital, by dr.(b)(6).Upon implanting the graft, dr.(b)(6) noted bleeding through the graft fabric.Due to this complication, the surgeon elected to use a different graft.Initial attempts to contact the surgeon failed due to a problem with the onetrack system.Three attempts have been made to contact the surgeon via email with the local representative, and we are still waiting for a reply.If more information is provided at a later date, this report will be updated.We cannot analyze the graft as it was discarded on the day of the surgery.A definitive conclusion of the cause of bleeding cannot be made due to limited information and the lack of the explanted graft for macro and microscopic analysis.¿ (4110/213) occurrence of bleeding events is calculated and reviewed monthly during quality meeting.In (b)(6) 2023, the bleeding rate on intergard / hemagard products was within the maximum anticipated by the product risk assessment.(4119/213) due to the limited information received from the initial reporter, no further investigation is possible.(4315) finally, based on the investigation findings and the medical review, no conclusion can be drawn on the exact origin of the adverse event.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.

Manufacturer Narrative

Corrected data: on block h6, the investigation conclusion code "4315" was replaced to "67" following receipt of new information from the surgeon.(4112/4111/213) the surgeon reached out to the medical affairs department on (b)(6) 2023.As a result of this discussion and new information received by the medical affairs department during the surgeon's call, the addendum below has been added to the initial medical review communicated in the mfg report #1640201-2023-00004 fu2." (b)(6) called on (b)(6) 2023, to discuss his complaint.He described his experience with the hemagard knitted axillo bifemoral graft that he had used for his case on (b)(6) 2023.We reviewed the differences between intergard and hemashield grafts and how they have different construction and different methods of collagen coating.Due to these differences, these two seemingly very similar grafts manufactured by the same company behave differently.Dr.Karimi confirmed that he was unaware he was using a different graft than he usually used for his cases.We also addressed that patients requiring axillo femoral bypass were challenging patients with many comorbidities and often presenting as coagulopathic; as such, they are more likely to bleed during prolonged surgeries.We agreed that using a different graft and the complexity of his patients probably explained why the graft appeared to be "bleeding" more than usual.We also agreed to stay in touch regarding his experience moving forward with intergard and hemashield grafts." (67) based on the conducted investigation and the addendum included in the medical review, no conclusion can be drawn on the exact origin of the observed bleeding.However, it was noted that the surgeon did not expect to find differences in behavior using intergard instead of hemashield grafts, in addition, the medical affairs department underlined that challenging patients with many comorbidities and often presenting as coagulopathic, requiring axillo-femoral bypass are more likely to bleed during prolonged surgeries.Moreover, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.(22) please note that bleeding is an undesirable side-effect as indicated in the instructions for use.

Event Description

Complaint #(b)(4).

• Brand Name: HEMAGARD KNITTED AXILLO
• 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: 16350821
• MDR Text Key: 309263159
• Report Number: 2242352-2023-00115
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401015109
• UDI-Public: (01)00384401015109
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: HGKAX0808
• Device Catalogue Number: HGKAX0808
• Device Lot Number: 18C15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2023
• Distributor Facility Aware Date: 04/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2023
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention