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

Model Number HERO 1001

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Occlusion Within Device (1423)

Patient Problems Unspecified Infection (1930); Occlusion (1984); Thrombosis (2100); Foreign Body In Patient (2687)

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the initial report, "successful surgery by dr.(b)(6) in (b)(6).The patient first presented for a declot of the hero graft to this access center on (b)(6) 2015.This was reported to be uneventful and flow was restored to the graft.The patient presented the following week with the graft clotted again.(b)(6) reported that they advanced a wire into the access, introduced a sheath and injected contrast.During this process, it was noted that the marker band on the distal end of the venous outflow component 'became loose and began to travel into the ventricle and eventually the lungs.' i asked that (b)(6) retrieve the records from the (b)(6) intervention to establish if they utilized a non-compliant balloon for that procedure as he did not know the answer to that question.He did not have the records available at the time of the call with him on (b)(6) 2016.The patient is reported to be asymptomatic." intervention/medical notes were received on 01/20/2016.The correct date of the first reported thrombectomy was (b)(6) 2015 and the second thrombectomy associated with the marker band dislodgment was (b)(6) 2015.Physician notes from (b)(6) 2015 indicate the following: "embolization of the right pulmonary artery by dislodgment of the metal ring marker of the tip of the hero device as detailed above.No shortness of breath.No changes in oxygen saturation on pulse oximetry.No arrhythmias on the cardiac monitor.This complication was discussed with the patient.I explained to him that any time a chest x-ray is done on him, this metal ring will be visualized on the right lung field." additional information is pending.The complaint investigation will address both hero 1001 and 1002 components but will be reported under hero 1001.

Manufacturer Narrative

According to the initial report, "successful surgery by dr.(b)(6) in (b)(6).The patient first presented for a declot of the hero graft to this access center on (b)(6) 2015.This was reported to be uneventful and flow was restored to the graft.The patient presented the following week with the graft clotted again.Wayne reported that they advanced a wire into the access, introduced a sheath and injected contrast.During this process, it was noted that the marker band on the distal end of the venous outflow component 'became loose and began to travel into the ventricle and eventually the lungs.' i asked that wayne retrieve the records from the (b)(6) intervention to establish if they utilized a non-compliant balloon for that procedure as he did not know the answer to that question.He did not have the records available at the time of the call with him on (b)(6) 2016.The patient is reported to me to be asymptomatic." the following additional information was requested of the interventional technologist at (b)(6), on (b)(6) 2016: date of implant (including details regarding approach/position of the implant technique), lot numbers, details regarding the thrombectomies (including the type/size, technique, and specific location of intervention), previous declots performed, details regarding the procedure in which the marker band dislodged, pertinent patient comorbidities, operative notes, and current patient status.He replied via email on (b)(6) 2016 stating "i will fax over to you the two operative reports dealing with the case where the radiopaque marker band on the hero was dislodged and traveled to the lung.Most of your other questions can be answered by dr.(b)(6)." thrombectomy intervention notes were provided via fax on (b)(4) 2016.A cryolife representative reviewed the thrombectomy intervention notes and provided on (b)(4) 2016 the following insight in comparison to the hero graft thrombectomy guidelines l7164: the order of steps the operator performed was incongruent with the guidelines.He pulled the arterial plug first, whereas the guidelines start with declotting the "the full length of hero graft prior to removing the arterial plug to decrease risk of pulmonary embolism." the operator used an "occluding balloon at the venous outflow." this is not a step specified in the guidelines.You will need to ask the operator which type of balloon (e.G.Compliant or non-compliant balloon) was used to occlude the voc.If it was a non-compliant balloon, this would be incongruent with the guidelines that states to use "a soft, compliant embolectomy balloon." the use of a "7x4 high pressure balloon" at the "graft hero connection" (i.E.Titanium connector) is not congruent with the guidelines.Instead, the guidelines state to do the following: introduce a 7f short vascular sheath near the arterial anastomosis.Inflate a soft, compliant embolectomy balloon at the radiopaque marker band of the 5mm venous outflow component.Do not advance the balloon beyond the radiopaque marker band to avoid dislodgement of the venous outflow component.Pull balloon back to the connector.Apply positive aspiration while deflating the balloon by approximately 10%.Failure to deflate the balloon may result in balloon perforation as the catheter passes through the connector.Pull balloon through the connector and reinflate within the 6mm graft.Extract clot at the introducer site.Declot the full length of hero graft prior to removing the arterial plug to decrease risk of pulmonary embolism.The implanting surgeons secretary nurse was contacted via phone on (b)(6) 2016 and she informed me that the surgeon was unavailable to speak.She suggested i contact the intervening surgeon regarding the methods of thrombectomy performed.The intervening surgeon was contacted via phone on (b)(6) 2016.He stated that he was in between cases.He informed me that he was not the implanting physician but the interventionalist who performed the angioplasty and was unable to answer any questions regarding implant.He stated that multiple angioplasties had been performed on the patient's clotted hero graft and was not able to provide any other specific information regarding dates or angioplasty techniques employed.When asked about the type of angioplasty balloon used, he did not remember specifics, but did state that it was a vaccess pta [percutaneous transluminal angioplasty] balloon.He stated that he followed the instructions for use (ifu) for performing the declots.On the last intervention, he stated that it was very difficult to advance the balloon through the graft, and was likely due to the clot in his opinion.He denied advancing the balloon past the end of the venous outflow component (voc).Additional information was received from the implanting physician's secretary nurse on (b)(4) 2016 via phone indicating that the hero graft was implanted on (b)(6) 2015.Lot numbers were not recorded.She also stated that the hero graft was explanted on (b)(6) 2016 due to infection.Implant and explant operative notes were faxed on (b)(4) 2016.Based on the medical notes provided, the patient received a left side hero graft on (b)(6) 2015.A thrombectomy was performed for a clotted graft on (b)(6) 2015 and again on (b)(6) 2015 in which dislodgement of the marker band occurred.Explant of a possibly infected hero graft was performed on (b)(6) 2016.As definite lots are unknown, the system was queried for potential lots shipped to the hospital in the six months prior to implant of the hero graft.Lots h15vc017, h15av010, h15vc018, h15av011, h15vc019, h15av012, and h15vc020 were returned in the query.The manufacturing records for these lots were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The hero graft was implanted on (b)(6) 2015.The surgeon accessed the left internal jugular (ij) vein, as the patient's right ij was documented to be chronically occluded.The surgeon attached the hero graft to an accuseal graft.Additionally, the patient was documented to require three thrombectomy procedures for a clotted hero graft.Two of the thrombectomy dates were (b)(6) 2015; the other thrombectomy date is unknown.Intervention notes for the known dates were provided.On (b)(6) 2015 the intervention note described the thrombectomy procedure: "access was declotted by passing a 4 fr fogarty across the arterial anastomosis and removing the plug and clot.Clot was aspirated from the sheath and repeated until no further significant clot was obtained.The central circulation was protected by inflating an occluding balloon at the venous outflow.Residual adherent clot was removed using balloon maceration." flow was restored by the procedure.However, a week later on (b)(6) 2015 the patient presented with another clotting event.During this intervention, the surgeon noted that there was difficulty advancing the guidewire through the voc tip.The surgeon noted that he felt it was likely due to the clot.He was able to advance the guide wire after using a straight vascular catheter.He also noted that he "advanced a 6 x 4 angioplasty balloon catheter through the tip of the catheter and inflated it over the guidewire." it was at this point that the surgeon realized that the metal voc marker band was dislodged and moved through the right atrium into the lungs.The patient remained asymptomatic during and after the dislodgement.The intervening surgeon provided additional information on the events.He stated that the angioplasty balloon used was "a vaccess pta balloon" and that he followed the ifu during the declot procedures.He specifically denied advancing the balloon past the end of the voc on the intervention performed on (b)(6) 2015.The information provided in the update and the intervention notes do not coincide, as the notes state that the balloon was inflated through the voc tip.The thrombectomy guidelines (https://www.Merit.Com/wp-content/uploads/2016/02/401520001-aherothromb-guideproc-brocus.Pdf) recommend that surgeons do not advance the balloon beyond the marker band: "inflate a soft, compliant embolectomy balloon at the radiopaque marker band of the 5mm venous outflow component.Do not advance the balloon beyond the radiopaque marker band to avoid dislodgment of the venous outflow component." it is unclear from the information provided what may have occurred to dislodge the voc marker band, but advancing the balloon too far into the tip may have played a role.As previously stated, there was no patient impact documented for the dislodged marker band.Partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft ifu.Hypercoagulable states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.Thrombosis is the most common cause of vascular access dysfunction.Additionally, missed hemodialysis sessions significantly increase the number of thrombosis episodes in arteriovenous fistulas (avfs) and arteriovenous grafts (avgs).Patient history was significant for a prior arteriovenous graft (avg) which required multiple thrombectomy procedures to maintain patency.Dialysis information, intervention notes from the third hero graft thrombectomy, and additional, related patient medical history were not provided.A history of hypercoagulability issues would put the patient at increased risk of the same issues with the hero graft.Without additional information the exact relationship between the hero graft and the thrombosis events cannot be determined.The patient required a hero graft explant on (b)(6) 2016.The explant occurred in light of a "possibly infected hero graft." the patient was previously seen for proteus septicemia and was treated with long term antibiotics.Due to the patient's history, the patient was followed with surveillance blood cultures.The nursing home where the patient was living reported a "positive culture" but the patient denied fever or chills.It was decided that the hero graft would be explanted.During the explant, the notes stated that "we saw, maybe, a little pus at the area of the anastomosis with the brace of the hero graft." the entire hero graft was sent for culture, but the results were not provided.The patient's history of infection elevated the risk of another infection.The hero graft ifu lists infection as a potential complication.Infection is a known complication of prosthetic arteriovenous (av) grafts.The patient selection considerations listed in the hero graft ifu states the patient should be screened for infection and ensure infection is resolved prior to hero graft implant procedure.It also states to prophylactically treat the patient in the peri-operative period with antibiotics, based upon the patient's bacteremia history.Primary infection directly caused by a hero graft is unlikely since the device undergoes a validated sterilization process.More likely causes of secondary infection include surgical site infection or infection related to cannulation.Additional information including dialysis information (first date of cannulation), exact treatment with antibiotics before and after hero graft implant, presence of a bridging catheter, and culture results were not provided.Without additional information, the relationship between the infection and the hero graft cannot be determined.Additionally, the patient reported here had a procedure modification to include an accuseal graft attached to the arterial graft component (agc).The hero graft ifu provides adequate instructions to implant the device in the intended configuration.Clinical outcomes with the hero graft in conjunction with an accuseal graft have not been evaluated by cryolife.The accuseal graft is an approved medical device to be used for av access, so one would anticipate similar clinical outcomes, including anticipated adverse events as those reported above.

Event Description

According to the initial report, "successful surgery by dr.(b)(4) in (b)(6).The patient first presented for a declot of the hero graft to this access center on (b)(6) 2015.This was reported to be uneventful and flow was restored to the graft.The patient presented the following week with the graft clotted again.(b)(6) reported that they advanced a wire into the access, introduced a sheath and injected contrast.During this process, it was noted that the marker band on the distal end of the venous outflow component 'became loose and began to travel into the ventricle and eventually the lungs.' i asked that (b)(6) retrieve the records from the (b)(6) intervention to establish if they utilized a non-compliant balloon for that procedure as he did not know the answer to that question.He did not have the records available at the time of the call with him on (b)(6) 2016.The patient is reported to me to be asymptomatic." intervention/medical notes were received on (b)(4) 2016.The correct date of the first reported thrombectomy was (b)(6) 2015 and the second thrombectomy associated with the marker band dislodgment was (b)(6) 2015.Physician notes from (b)(6) 2015 indicate the following: "embolization of the right pulmonary artery by dislodgment of the metal ring marker of the tip of the hero device as detailed above.No shortness of breath.No changes in oxygen saturation on pulse oximetry.No arrhythmias on the cardiac monitor.This complication was discussed with the patient.I explained to him that any time a chest x-ray is done on him, this metal ring will be visualized on the right lung field." additional information is pending.The complaint investigation will address both hero 1001 and 1002 components but will be reported under hero 1001.

• 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: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5404604
• MDR Text Key: 37340648
• Report Number: 1063481-2016-00011
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: HERO 1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2016
• 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): Life Threatening; Other
• Patient Age: 66 YR