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

Model Number HGK0008-40

Device Problem Off-Label Use (1494)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/11/2023

Event Type  Injury  

Event Description

It was reported to intervascular that during a surgery the involved graft was used for cannulation.As reported by the reporter "unfortunately, it was not sealing.The blood was passing through graft wall in huge quantities.The worst leakage was where the cannula was attached to the graft, but also elsewhere there was significant leakage.As they compressed the graft with the fingers, the situation worsened considerably.The blood loss was enormous, they had to aspirate and return to heart-lung.".

Manufacturer Narrative

(4115) based on initial information received, it appears that the product was not available for testing.It is assumed that the product was discarded.In addition, the product, and any fragments, did not remain implanted.(4111/3233) more information about the event has been requested to the surgeon in order to better understand the adverse event.Responses are pending.(4109 / 213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 23c16.(3331/213) the device history records review concluded that there was no non-conformance in relation with the event reported.(11/213) one retention sample from same sterilization lot number was selected based on the same coating parameters and same textile parameters as the involved device.A visual inspection performed by the quality control technician with the manufacturing supervisor, concluded that the product is in compliance with the specification.This retention sample also underwent water permeability testing.The test result indicated a value of 0,03 ml/cm²/min, which is well within product specifications (< 5 ml/cm²/min).(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.H3 other text : 4115 - based on initial information received, it appears that the product was not available for testing.It is assumed that the product was discarded.In addition, the product, and any fragments, did not remain implanted.

Event Description

Complaint # (b)(4).

Manufacturer Narrative

(4111) more information about the event has been requested to the surgeon in order to better understand the adverse event.Additional information was received as follows: 1.Injury information: there is no consequence for the patient.The bleeding was diffuse.2.Preexisting medical conditions: vascular diagnosis: aortic regurgitation.Hypercholesterolemia.Hypertension.Anticoagulants was administrated however no detail were obtained.3.Event management the blood loss was enormous, they had to aspirate and return to heart-lung.Packed red blood cells was administrated to the patient.There are intraoperative challenges however no detailed were obtained.(4112/4248) the case and its investigation have been reviewed by the medical affairs department whose assessment is below: this is a complaint from (b)(6).This complaint refers to a case of bleeding during cardio pulmonary bypass.A hemagard knitted straight graft was used as an extracorporeal conduit.Upon establishing blood flow through the graft, it was noted to be bleeding profusely throughout, mainly near the connection with the cannula.The blood loss was considered to be significant, but no estimate of the quantity was provided in the complaint.A cell saver was used to salvage the intraoperative blood loss.An unknown quantity of packed red blood cell units was transfused.The patient is an 80-year-old male with a history of hypertension and hypercholesterolemia.A standard investigation was performed including a review of historical data that did not show any similar complaint for the same sterilization lot; a review of the device history records did not show non-conformance.The sample did not remain implanted yet was not returned for analysis.A retention sample was examined internally by the quality control technician as well as the manufacturing supervisor who both concluded that the product was in compliance with the specification.The instructions for use of hemagard knitted vascular grafts clearly states that use of this device for extracorporeal circulation is contraindicated.Due to the lack of the device in question for analysis a definitive conclusion cannot be reached as to the cause of bleeding.(4110/213) occurrence of bleeding events and off-label use (olu) bleeding events are reviewed monthly during quality meeting, as per internal procedures.During last meeting ((b)(6) 2024), bleeding events and olu bleeding events rates for intergard / hemagard grafts were within the maximum anticipated by the product risk assessment.(4315) based the investigation findings and the medical review, no conclusion can be drawn on the exact origin of the adverse event, considering the inability to analyze the involved device and the off-label use of the device.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.

• 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): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 13705 ; FR 13705
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 13705 ; FR 13705 ; 442084646
• MDR Report Key: 18326461
• MDR Text Key: 330497815
• Report Number: 2242352-2023-01033
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014140
• UDI-Public: (01)00384401014140
• Combination Product (y/n): N
• Reporter Country Code: SI
• 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
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HGK0008-40
• Device Catalogue Number: HGK0008-40
• Device Lot Number: 23C16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2024
• Distributor Facility Aware Date: 02/01/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2024
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female