MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD GOLD KNITTED STRAIGHT; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M002020952100
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(4117) the actual device involved in the event is not accessible for testing.(3331/213) the device history records review concluded that there was no non-conformance / planned deviation in relation with the event reported.(4109/213) the review of historical data indicated that another complaint in relation with the same event type "bleeding during surgery (off-label use)" was reported for the same sterilization lot number 19f05.The qa investigation of complaint concluded that the product was manufactured according and in compliance with the specifications.The use described in the complaint is considered off-label (used as a conduit for an impella device) and could cause the event.However, it is not the same kind of off-label use as the current case.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
This complaint information was received through a fda medwatch report (report and was forwarded to the manufacturer on 21 feb 2022.According to the medwatch report, complaint is as follows: "describe the event or problem: hemashield gold knitted microvel straight double velour vascular graft failed while cannulating for veno-arterial extracorporeal membrane oxygenation (va-ecmo).Replaced with new graft.What was the original intended procedure?: veno-arterial extracorporeal membrane oxygenation (va-ecmo) support.What problem did the user have (check all that apply): device failed (e.G.Broke, couldn't get it to work or stopped working);" to be noted, the use of hemashield gold knitted graft for cannulation in veno-arterial extracorporeal membrane oxygenation (va-ecmo) support is not an approved indication.After contacting the initial reporter, we obtained the following information about the event: according to the medical record, the patient experience bleeding from the right axillary arterial graft site.The medical record does not indicate the amount of blood loss.It is unknown if the procedure was significantly prolonged.According to the medical record, the patient was on brilinta 90mg tid.The device is not available for inspection.Complaint #(b)(4).
Event or Problem Description
See mfg initial report #1640201-2022-00007.Complaint #(b)(4).
Additional Manufacturer Narrative
(4112/4248) the case was evaluated by the medical affairs whose assessment is as follows: "the event was reported via a fda medwatch report where the reporter described an incident of a patient who underwent va ecmo support utilizing a hemashield gold knitted straight graft for cannulation.It is stated that there was bleeding from the right axillary arterial graft site.The bleeding issue was resolved by replacing the graft with an alternate graft.The amount of blood loss and if the procedure was significantly prolonged are unknown.No other patient harms were reported.The report states that the graft which was replaced was discarded and therefore will not be returned for investigation.Of significance, the past medical history notes that the patient was taking a blood thinner (brilinta) prior to surgery.Post-marketing review revealed one other similar event of bleeding when a hemashield knitted graft was used in the same manner (as conduit for cannulation during ecmo).From the limited information provided, it is unclear what may have caused the bleeding in this case.As the hemashield knitted grafts are indicated for use in the repair or replacement of arteries affected by aneurismal or occlusive disease, the use of the graft as a conduit for cannulation during va ecmo is considered an off-label use." (67) no conclusion can be drawn since the product is not available for investigation.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.(24) please note that, as per the product instructions for use, the use of hemashield gold knitted vascular grafts as a conduit for cannulation is not an approved indication and may lead to excessive bleeding.Indeed, hemashield gold knitted vascular grafts are indicated for use in the treatment of aneurismal aneurismal or occlusive diseases.

• Brand Name: HEMASHIELD GOLD KNITTED STRAIGHT
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• 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: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 13792981
• Report Number: 2242352-2022-00238
• Device Sequence Number: 11718413
• Product Code: MAL
• UDI-Device Identifier: 00384401017622
• UDI-Public: (01)00384401017622
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K954848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022
• Report Date (Section F): 05/04/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: M002020952100
• Device Catalogue Number: M002020952100
• Device Lot Number: 19F05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRILINTA 90MG TID
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Date Report Sent to FDA: 05/04/2022