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

Model Number HGKAX1010

Device Problems Off-Label Use (1494); Material Puncture/Hole (1504)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/21/2023

Event Type  Death  

Event Description

It was reported to intervascular by the hospital that a patient presented with st segment elevation myocardial infarction (stemi) and had an intra-aortic balloon pump (iabp) placed.Plan was to initiate veno-arterial extracorporeal membrane oxygenation (va ecmo) then have coronary stent placement.Procedures performed in catherization laboratory.Right groin with 8fr catheter and iabp but was occlusive due to severe peripheral vascular disease (pvd).Femoral venous access obtained for ecmo and left axillary cutdown performed for arterial access.End to side anastomosis performed to left axillary artery and hemagard graft.Impella inserted into 1 limb with 3/8-3/8 connector to other limb and then to ecmo.Flow rate was 3.5 l/min with system pressure of 220-230 mmhg.Pinhole bleeding occurred along graft, suture lines, and seam of branched graft.Hemostatic agents used without desired results which included evarrest, evaseal, nu-knit, and quick clot.Activated clotting time (act) was reported to be 140's and no heparin was given during the procedure.Patient with history of taking elliquis for atrial fibrillation.Impella was removed with clamping of graft limb without resolution of the pinhole bleeding.Ecmo limb with more bleeding than impella limb.Ecmo switched to limb originally with impella but bleeding did not resolve.Patient did not survive the procedure graft sample was taken and kept but novant risk management is keeping for evaluating.Sample not release to rep for return to getinge at this time.Will be notified if sample released and will return in biokit.The event was also reported to fda (ref mw512281) with the following description: "underwent heart cauterization for possible intervention and insertion of impella and ecmo due to cardiogenic shock.During insertion of bifemoral graph via cutdown to left artery, uncontrolled bleeding.Bleeding at graph site described as "spraying/ appearing as a sprinkler".Estimated blood loss >4l.Unable to control bleeding, patient expired.Therapeutic range for heparin.".

Manufacturer Narrative

(10/3233) it was indicated that remaining part of the product should be available for testing.Product return is pending.(3331/213) the device history records review concluded that there was no non-conformance in relation with the event reported.(4109/3233) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 22k06.(4110/213) from the outset of the investigation, the occurrence of off label use (olu) bleeding events discussed during the previous monthly quality meeting was reviewed.The occurrence rate of olu bleeding events on intergard/hemagard products was within the maximum anticipated by the product risk assessment.(4111/4248 ) as part of the investigation the surgeon and initial reporter were contacted by our medical affairs department in order to better understand the reported event.The event description was updated consequently.The information received suggests that the device has been used for an unapproved intended use.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

Corrected data : initially on block h6, the device codes were "1504" and "1494".Following investigation findings, it appears that device code "1504" is no longer appropriate and should be deleted.Initially on block h6, the method code "10" indicated that the product was available for analysis, however, and despite our requests the involved device fragments were kept by the hospital.Additional manufacturer narrative: (4114) the remaining fragments of the involved graft were kept by the hospital despite our return requests, therefore no laboratory analysis could be performed.The hospital has offered us the opportunity to visually inspect the device on 03-nov-2023 (in charlotte, nc, usa).The corporate senior medical affairs manager visited the hospital on 03-nov-2023 and took pictures of the graft fragments.However, following this inspection no pertinent analysis could be performed.(4111/4248) the case and its investigation have been reviewed by the medical affairs department whose assessment received is below: "this complaint refers to a case of bleeding during the resuscitation via extra corporeal membrane oxygenation (ecmo), and using an impella heart pump (abiomed) of a patient status post stelevated myocardial infarction (stemi).On (b)(6), 2023, the patient, a 58 y/o female was transferred emergently to (b)(6) from a rural care center in cardiogenic shock.She was immediately taken to the icu for emergent stenting of her coronary blockage and ecmo therapy.Due to blockage of both femoral arteries that arrived with catheter and a balloon pump, access was achieved through the left axillary artery via a hgkax1010 - hemagard knitted axillo bifemoral graft that was anastomosed for this purpose.The impella device was placed through the main branch, and the ecmo catheter was connected to the limb.Bleeding was observed throughout the graft, but mainly from the limb through which the impella device was inserted.The bleeding was described as if the graft had multiple needle perforations.The graft was wrapped with a fibrin sealant patch, oxidized cellulose path and surgical sealants were used to try to establish hemostasis unsuccessfully.At this point the impella device was removed and placed in the main branch of the graft; the limb was tied off and removed.As pressure continued to drop, manual chest compressions were performed and ultimately the patient expired.It was estimated that the patient lost over 4 liters of blood.The patient presented severe diffuse vascular disease, smoker, taking apixiban (eliquis) for atrial fibrillation.I met with dr.(b)(6) at (b)(6) hospital on (b)(6), 2023 and reviewed the case.I traveled to the hospital a second time on (b)(6), 2023, to inspect the limb of the graft and take the photographs included above.Upon inspection there was mold growing on segments of the graft¿s exterior and lumen.The graft was presented to me in a small specimen cup, without formalin.Retention samples were not available for testing.Without the macroscopic and microscopic analysis, it is difficult to establish if there was a defect in the graft.The analysis may also have been inconclusive.Patients under treatment with oral anticoagulants like apixaban that have not suspended treatment may encounter serious bleeding.Knitted grafts are indicated for use in the abdominal aorta and lower extremities due to greater porosity and compared to woven grafts.Intergard knitted vascular grafts are not intended for use in the thoracic aorta.Use as a perfusion branch during extracorporeal circulation is also contraindicated in the ifu." the case was escalated to the intervascular management team.Below is the final medical assessment conclusion following this escalation: "the medical escalation meeting was held (b)(6) 2023 triggered by the death of the patient.The complaint, the investigation and the medical assessment were reviewed.It was determined that no additional tests can be performed towards this investigation due to the lack of a retention sample, as well as the fact that the hospital has refused to provide the remnants of the graft.The points that remain of interest are the off-label use of the graft as a perfusion branch, the use of direct oral anticoagulants (apixaban) the patient was taking, and the pressure and flow through the graft of the impella device and concomitant ecmo.The investigation remains inconclusive due to the inability to submit the graft segment for inspection and analysis, as well as the lack or a retention sample for additional testing of the lot." (3331/213) an internal non-conformity report was opened in order to perform further investigation due to the nature of the incident.A thorough manufacturing data analysis was performed considering the available details regarding the incident.The non conformity report concluded that based on the analysis of the investigation findings and the medical review there are no element that could question the quality of the product at the time of manufacturing.As the product was used off label and the inability to analyze the remained fragments, it is not possible to conclude on the exact origin of the cause of the reported incident.(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) 2023), bleeding events and olu bleeding events rates for intergard / hemagard grafts were within the maximum anticipated by the product risk assessment.(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, considering the inability to analyze the remaining fragments and the off-label use.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.H3 other text : 4114 - the remaining fragments of the involved graft were kept by the hospital despite our return requests.

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: 17571637
• MDR Text Key: 321414107
• Report Number: 1640201-2023-00024
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014478
• UDI-Public: (01)00384401014478
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HGKAX1010
• Device Catalogue Number: HGKAX1010
• Device Lot Number: 22K06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPELLA, EVARREST, EVASEAL, NU-KNIT, QUICK CLOT
• Patient Outcome(s): Death
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 64 KG