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

Model Number HGK0010-100

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

(10/3233) the involved device was received at intervascular and it will be sent to an external and independent laboratory for analysis.The investigation is ongoing.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 18l15.However, on the this sterilization lot, it should be noted that there is another complaint for bleeding caused by a 1mm hole at the crotch of the bifurcated graft.The investigation suggested that the product was not defective at the time of manufacture and the suspected origin was that the reported event occurred during handling, at the time of use.(3331/3233)the device history records review is ongoing.(4102/3233) one retention sample from another sterilization lot number with the same coating and textile parameters as the involved was selected.A visual inspection and a waterpermeability testing will be performed.(4111/3233) as part of the investigation, attempts will be made to establish contact with the surgeon.These attempts are undertaken with the aim of clarifying the incident and acquiring additional details regarding the patient's condition.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

It was reported to intervascular that during a transcatheter aortic valve replacement (tvar) surgery , the graft involved ( hgk 10-100) was leaking through the whole graft.The graft was used as a temporary ax-fem bypass graft for blood flow during the tvar.The involved graft was leaking onto the floor throughout the whole case.They did not replace the prosthesis and used it until the tvar portion was finished.The graft was removed and the vessels were anastomosed.On (b)(6) 2023, it was reported that the patient was not doing well, no further information about the patient's condition and his current status was provided.The surgeon is a vascular surgeon highly experienced with getinge products.Complaint #(b)(4).

Event Description

Complaint # (b)(4).

Manufacturer Narrative

(3331/213) the device history records review concluded that no deviation was identified in relation with the reported event.(4102/213) one retention sample from another sterilization lot number with the same fabric type (knitted), the same coating date and coating parameters as the involved product was selected.A visual inspection of the retention sample was performed by two qualified quality control (qc) technicians, which concluded that the product is in compliance with the specifications at the time of qc inspection.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

(b)(4).

Manufacturer Narrative

(10/213/3233) the involved device has been sent to an external and independent laboratory for analysis.The involved graft underwent a macroscopic analysis before cleaning, which did not reveal any macroscopic degradation on the pet membrane.Further microscopic analysis after cleaning 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

(10/4248) following the macroscopic analysis by the external and independent laboratory, the involved device underwent an enzymatic cleaning for a macroscopic and microscopic analysis which does not reveal any degradations of the textile structure.However, a single hole is visible, the lab concluded that this hole had been caused by a surgical instrument, specifically a needle.(11) the completion of the investigation conclusion is still ongoing.A follow-up report will subsequently be sent.

Event Description

Complaint#: (b)(4).

Manufacturer Narrative

(4112/213/4248) the case and its investigation have been assessed by the medical affairs department whose conclusion is below: "the use of hemagard knitted vascular grafts for extracorporeal circulation is contraindicated as mentioned in the instructions for use.The investigation performed as well as the review of manufacturing records did not show any evidence that this graft was defective.Off label use of hemagard knitted vascular grafts for extracorporeal circulation may result in excessive bleeding.A definitive conclusion of the cause of bleeding is not possible." (4315) based on the analysis of the investigation findings and the medical review, no conclusion can be drawn on the exact origin of the adverse event.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.(24) it should be noted that as per the product instructions for use, intergard/hemagard knitted vascular grafts are not intended for use as perfusion branch during extracorporeal circulation, as this may lead to excessive bleeding.Indeed, intergard / hemagard knitted vascular grafts are indicated for surgical repair, bypass, or replacement of the abdominal aorta and peripheral arteries, when open surgical operation is required.

Event Description

Complaint#: (b)(4).

Event Description

Complaint # (b)(4).

Manufacturer Narrative

Corrected data: the device code "1494" was updated to "2993".The investigation finding "4248" is cancelled.The investigation conclusions "24"is cancelled.Addtl mfg narrative: the initial medical review was completed and signed on february 2024 by the senior medical affairs manager.An unrelated meeting to discuss off-label use, along with a consultation with a practicing vascular surgeon, clarified that the use mentioned in this complaint, temporary para-anatomic axilofemoral bypass, should not be considered off-label use of hemagard knitted vascular grafts.This complaint was originally labeled as off label due to the language in the ifu that specifies that: ¿intergard/hemagard knitted vascular grafts are not intended for use as perfusion branch during extracorporeal circulation, as this may lead to excessive bleeding.¿ extracorporeal circulation is defined as a technique that replaces the heart and lungs in replacing perfusion and oxygenation.The use of the graft in this complaint does not classify as extracorporeal circulation.The initial classification of the complaint was incorrect; it was determined that the use of the graft described in this complaint was on label.A definitive conclusion of the cause of bleeding is still not possible.(4315) based on the analysis of the investigation findings and the medical review, no conclusion can be drawn on the exact origin of the adverse event.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.

• Brand Name: HEMAGARD KNITTED STRAIGHT
• 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: 17943531
• MDR Text Key: 325766338
• Report Number: 2242352-2023-00865
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401015093
• UDI-Public: (01)00384401015093
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: HGK0010-100
• Device Catalogue Number: HGK0010-100
• Device Lot Number: 18L15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2024
• Distributor Facility Aware Date: 04/09/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2024
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Other