MAUDE Adverse Event Report: CRYOLIFE, INC. HERO GRAFT; VASCULAR GRAFT

Model Number HERO 1001

Device Problems Complete Blockage (1094); Migration or Expulsion of Device (1395); Occlusion Within Device (1423)

Patient Problems Occlusion (1984); No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2015

Event Type  Injury  

Event Description

According to the field assurance notification form, "got an email from the assistant vascular surgeon that one patient came with an occluded hero.She does not have any experience with the thrombectomy of the hero and is asking for help." additional information was received from the surgeon through the representative.Both the voc and agc are occluded, as when it starts somewhere the whole graft occludes.A clear identification of the irigin is difficult, but she has seen some sort of pseudo neo intima hyperpasie.The surgeon doesn't know when the graft was originally implanted as she was not the one who implanted it.This was the hero grafts first revision.She used a fogarty catheter and afterwards a ring stripper over the wire.When she removed the catheter, she removed a pseudo intimal layer.The occlusion was first noted on (b)(6) 2015 in the dialysis unit, exactly how is undetermined.The revision was performed on (b)(6) 2015.The patient is doing well, discharged and back on dialysis.Dr.(b)(6) remarked, that the venous outflow component was almost in the ivc.She made this remark as an observation and not as an explanation.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Manufacturer Narrative

According to the report, "got an email from the assistant vascular surgeon that one patient came with an occluded hero.She does not have any experience with the thrombectomy of the hero and is asking for help." additional information was received from the surgeon through the representative.Both the voc and agc are occluded, as when it starts somewhere the whole graft occludes.A clear identification of the origin is difficult, but she has seen some sort of pseudo neo intima hyperpasie.The surgeon doesn't know when the graft was originally implanted as she was not the one who implanted it.This was the hero grafts first revision.She used a fogarty catheter and afterwards a ring stripper over the wire.When she removed the catheter, she removed a pseudo intimal layer.The occlusion was first noted on (b)(6) 2015 in the dialysis unit, exactly how is undetermined.The revision was performed on (b)(6) 2015.The patient is doing well, discharged and back on dialysis.Dr.(b)(6) remarked, that the venous outflow component was almost in the ivc.She made this remark as an observation and not as an explanation.Although this medwatch report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 were investigated.A review of manufacturing records could not be performed as a lot number was not provided.Furthermore, as the date of implant is unknown, shipping records could not be queried for possible lot numbers involved in the reported event.A review was performed of the available information.The patient was implanted with a hero graft, but the date of implant is not known.In early (b)(6) 2015, an occlusion was identified.Partial stenosis or full occlusion of prosthesis or vasculature is listed on the hero instructions for use (ifu) as a potential vascular graft and catheter complication.In this case, the surgeon chose to treat the occlusions with a thrombectomy procedure including use of a fogarty catheter and a ring stripper over the wire and removal of a layer of pseudo neointimal hyperplasia, which resulted in the patient's discharge and return to dialysis.The surgeon observed that the venous outflow component (voc) was "almost in the inferior vena cava (ivc)." it is unclear where the voc was originally placed in the hero graft implant procedure, as the operative notes are unavailable.Due to the lack of information, it cannot be confirmed whether or not the device migrated.However, device migration is listed on the ifu as a potential vascular graft and the catheter complication.Directions on how to place the device are provided in the ifu; surgeons are directed to place the venous outflow component (voc) tip in the mid to upper right atrium.It is unclear what impact the voc position had on the patient and if the voc did in fact migrate.The following information was not available for consideration in the assessing risk of occlusion and potential device migration: patient medical history, operative notes, hero implant history, and details on the origin/presentation of the reported occlusion.An increased risk for graft thrombosis could be caused by a hypercoagulability state or impaired blood flow through the graft.Precautions regarding inadequate anticoagulation are provided in the hero ifu.At this time, the role of the hero graft in the aforementioned clotting and potential device migration cannot be determined.The root cause for the reported event is unknown.This event represents a known potential complication of the hero graft which is outlined in the device's ifu.The ifu provides information and instructions such as, "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication," "determine the venous outflow component length required to make the connection to the arterial graft component at the final dpg (deltopectoral groove) location.Utilizing a pair of heavy duty scissors, straight cut the venous outflow component to the desired length ensuring that the cut is square to the venous outflow component.Carefully position the titanium connector in the soft tissue at the dpg.Reposition the arterial graft component from the arterial end to remove excess material.Cut the arterial length avoiding excessive tension and no kink," "evaluate for steal syndrome during the implant procedure with doppler of the radial and ulnar arteries.If steal syndrome symptoms occur, consider surgical interventions such as: dril (distal revascularization-interval ligation) procedure; banding, though this may reduce the flow in the hero graft; proximalization of the inflow," and "follow kdoqi guidelines for graft assessment, preparation and cannulation.The arterial graft component requires 2-4 weeks to incorporate prior to cannulation.Swelling must subside enough to allow palpation of the entire arterial graft component.Rotation of cannulation sites is needed to avoid pseudoaneurysm formation.A light tourniquet may be used for cannulation as the thrill and bruit may be softer than a conventional eptfe graft due to the elimination of the venous anastomosis.Post-dialysis, and following needle removal, apply moderate digital pressure at the puncture site until hemostasis is achieved.To decrease the risk of an occlusion, do not use mechanical clamps or straps.".

Event Description

According to the field assurance notification form, "got an email from the assistant vascular surgeon that one patient came with an occluded hero.She does not have any experience with the thrombectomy of the hero and is asking for help." additional information was received from the surgeon through the representative.Both the voc and agc are occluded, as when it starts somewhere the whole graft occludes.A clear identification of the origin is difficult, but she has seen some sort of pseudo neo intima hyperpasie.The surgeon doesn't know when the graft was originally implanted as she was not the one who implanted it.This was the hero grafts first revision.She used a fogarty catheter and afterwards a ring stripper over the wire.When she removed the catheter, she removed a pseudo intimal layer.The occlusion was first noted on (b)(6) 2015 in the dialysis unit, exactly how is undetermined.The revision was performed on (b)(6) 2015.The patient is doing well, discharged and back on dialysis.Dr.(b)(6) remarked, that the venous outflow component was almost in the ivc.She made this remark as an observation and not as an explanation.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4918873
• MDR Text Key: 18655498
• Report Number: 1063481-2015-00112
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention