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

Model Number HERO 1001

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Coagulation Disorder (1779); Death (1802)

Event Type  Death  

Event Description

A hero patient died.The patient was declotted at the access center, went back for treatment then clotted again.The second declot of the hero was unsuccessful so the patient returned to the dialysis unit with a femoral catheter.The patient was dialyzed through the femoral catheter but passed at home after the treatment.As it is unknown wether hero 1001 or hero 1002 contributed to the event, out of caution, both product codes are being investigated.This medwatch is for product code hero 1001.

Event Description

The patient present to dr.(b)(6) with a "torn" graft which she said was caused by the dialysis center.She cut the hero graft portion near the should and anatomized another ptfe graft the left over hero graft and to the brachial artery.Over a month later the patient complained of chest pain and the patient was taken to the er where a cardiac catheterization was performed.Shortly thereafter the patient expired from an mi.The patient was severely obese, hypotensive, and had "one maybe two" intervention performed during the time the patient had the hero graft.The surgeon feels the hero graft had noting to do with the adverse event.The information above which was received from dr.(b)(6) is the more reliable information.The information, which was received from (b)(4), is from an unknown source and would have had to go through a translator.At this time the complaint files are moving forward with the information above.As it is unknown wether hero 1001 or hero 1002 contributed to the event, out of caution, both product codes are being investigated.This medwatch is for product code hero 1001.

Event Description

The patient present to dr.(b)(6) with a "torn" graft which she said was caused by the dialysis center.She cut the hero graft portion near the should and anatomized another ptfe graft the left over hero graft and to the brachial artery.Over a month later the patient complained of chest pain and the patient was taken to the er where a cardiac catheterization was performed.Shortly thereafter the patient expired from an mi.The patient was severely obese, hypotensive, and had "one maybe two" intervention performed during the time the patient had the hero graft.The surgeon feels the hero graft had noting to do with the adverse event.The information above which was received from dr.(b)(6) is the more reliable information.The information, which was received from (b)(6), is from an unknown source and would have had to go through a translator.At this time the complaint files are moving forward with the information above.

Manufacturer Narrative

Description of event, corrected to "the patient present to dr.(b)(6) with a "torn" graft which she said was caused by the dialysis center.She cut the hero graft portion near the should and anatomized another ptfe graft the left over hero graft and to the brachial artery.Over a month later, the patient complained of chest pain and the patient was taken to the er where a cardiac catheterization was performed.Shortly thereafter, the patient expired from an mi.The patient was severely obese, hypotensive, and had "one maybe two" intervention performed during the time the patient had the hero graft.The surgeon feels the hero graft had noting to do with the adverse event.The information above which was received from dr.(b)(6) is the more reliable information.The information, which was received from (b)(6), is from an unknown source and would have had to go through a translator.At this time, the complaint files are moving forward with the information above.As it is unknown wether hero 1001 or hero 1002 contributed to the event, out of caution, both product codes are being investigated.This medwatch is for product code hero 1001." manufacturer narrative: this investigation is currently ongoing.Any additional information will be provided in the follow-up report.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Manufacturer Narrative

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

Manufacturer Narrative

According to the report from the cryolife representative, while at the booth at the (b)(6) meeting in (b)(6) informed the cryolife representative that she was in (b)(6) last week and two hero patients had died.This complaint was initiated for one of the deaths.The patient was declotted at the access center, went back for treatment then clotted again.The second declot of the hero was unsuccessful so the patient returned to the dialysis unit with a femoral catheter.The patient was dialyzed through the femoral catheter but passed at home after the treatment.Additional information about the deaths including lot numbers, date of implant, date of event, and information regarding cause of death was requested.The cryolife representative shared the following information which he had received from dr.(b)(6), the implanting surgeon, on (b)(6) 2014, "i was finally able to speak to the implanting surgeon, dr.(b)(6), today at 4:45pm.She informed me there had only been two issues with the 5 hero patients she has implanted.1 had steal two weeks out and hero was explanted immediately.Patient is fine and receiving dialysis through catheter.The second patient presented to dr.(b)(6) with a 'torn' graft which she said was caused by the dialysis center.She cut the hero graft portion near the shoulder and anatomized another ptfe graft to the left over hero graft and to the brachial artery.Over a month later the patient complained of chest pain and the patient was taken to er where a cardiac catheterization was performed.Shortly thereafter the patient expired of an mi [myocardial infarction].The patient was severely obese, hypotensive and 'one maybe two' interventions were performed during the time the patient had the hero.She feels hero had nothing to do with the adverse event." cryolife confirmed that the surgeon was in fact talking about the same two patients that were originally reported by (b)(6); the representative stated that they were.Dr.(b)(6) is the more reliable source of information.The information, which the cryolife representative received from (b)(6), is from an unknown source and would have had to go through a translator.The information investigated in the file was that which came from dr.(b)(6).This complaint investigates the patient who passed away from the mi.Multiple attempts were made to gain additional information from the hospital and the implanting surgeon.The manufacturing records for lots h14vc010 and h14 av007 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.According to the information provided, the hero graft required revision following a tear in the graft portion of the device.According to the surgeon, the tear was caused by the dialysis center.The cause of the tear cannot be determined; however, the repeated cannulation in the same area could potentially weaken the graft leading to pseudoaneurysm formation.The ifu states that the cannulation site should be rotated to avoid pseudoaneurysm formation.The ifu lists patient death a potential post-operative complication; table 2 of the ifu shows rates of 0% -1.9%.Additionally gage, et al., reported 29 deaths, of which 4 were reported within the immediate 2 week post-operative period.The authors attributed the observed death rate to, "the extreme morbidity of the end stage vascular access patients with central venous pathology." with the information available, it is not possible to determine the relationship, if any, between the cause of death to the hero graft, although the surgeon communicated that she did not think the hero graft was related or associated with this event.Patient selection criteria to minimize the risks of post-operative complications are also listed in the ifu.This event represents known potential complications of the hero graft which are outlined in the device's ifu.The ifu lists death and myocardial infarction as potential intraoperative and post-operative complications associated with the use of the hero graft.These known potential complications are common among all arteriovenous grafts, and do not suggest that there is a deficiency in the hero or the hero ifu.There is no evidence to suggest that an error occurred in processing or production.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4268254
• MDR Text Key: 5003411
• Report Number: 3006945290-2014-00096
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K121532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• Device Lot Number: H14VC010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death