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

Model Number HERO 1001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Sudden Cardiac Death (2510)

Event Type  Death  

Manufacturer Narrative

Note: this mdr is being re-sent as initial.This investigation is currently ongoing.Any add'l info will be provided in the f/u report.

Event Description

According to the initial report, the following were indicated: the surgeon reported the use of the hero graft with the venous outflow component in a subclavian vein with icd (implantable cardioverter defibrillator) lines.This was done in order to preserve the vessel (before it occluded) for vascular access.(b)(6), associate director vascular technologies, instructed the surgeon that this use of the hero graft was not approved in the instructions for use.Specifically, it says "do not place the hero graft in the same vessel as a catheter, defibrillator or pacemaker lead." the surgeon reported that one patient died of heart attack after 1 year with the hero graft, and the death was not related to the hero graft.Correspondence from the hospital representative stated "the cases he spoke of happened to have had hero's but they were not involved with any of the patient's problems.He does not care to participate in the investigation and provide his patient information since your product was not involved in the patient care and subsequent issues." this complaint investigation will be evaluate both hero 1001 and 1002 components, but the report will be submitted under hero 1001.

Manufacturer Narrative

According to the initial report, the following were indicated: the surgeon reported the use of the hero graft with the venous outflow component in a subclavian vein with icd (implantable cardioverter defibrillator) lines.This was done in order to preserve the vessel (before it occluded) for vascular access.(b)(4), associate director vascular technologies,instructed the surgeon that this use of the hero graft was not approved in the instructions for use.Specifically, it says "do not place the hero graft in the same vessel as a catheter, defibrillator or pacemaker lead." the surgeon reported that one patient died of heart attack after 1 year with the hero graft, and the death was not related to the hero graft.Correspondence from the hospital representative stated "the cases he spoke of happened to have had hero's but they were not involved with any of the patients problems.He does not care to participate in the investigation and provide his patient information since your product was not involved in the patient care and subsequent issues." this complaint investigation will be evaluate both hero 1001 and 1002 components, but the report will be submitted under hero 1001.A request for information email was sent to the surgeon on 11/03/2015 requesting the following information: lot numbers, date of implant, date of death, pertinent comorbidities, and progress/operative notes.The surgeon replied on (b)(6) 2015 stating "that's a lot of information to gather.Neither myself or the hospital consider this an adverse event" and instructed further queries be made to the hospital risk manager.The email chain was forwarded to the risk manager on 11/17/2015 and a response was received on 11/19/2015.She stated the following: "i have met with [the surgeon] and he states that he has never had a case that involved a problem, infection, malfunction or any other problems related to the hero.The cases he spoke of happened to have had hero's but they were not involved with any of the patients problems.He does not care to participate in the investigation and provide his patient information since your product was not involved in the patient care and subsequent issues." manufacturing records were not reviewed as date of implant and lot numbers are unknown.The patient's date of hero graft implant is unknown; however, the patient had the hero graft approximately one year before death.This case is one of four performed by the surgeon using the hero graft with the venous outflow component (voc) in a subclavian vein with icd lines.The surgeon chose this implant approach to preserve the vessel before it occluded and stated that the vein was "big enough to accommodate the voc and the icd lines in all the cases." the only additional information on this patient was that the patient "died of a heart attack after 1 year with the hero graft." the risk management contact for this case reiterated the surgeon's opinion that the four aforementioned cases "happened to have had hero's but they were not involved with any of the patients problems." the following information is not currently available: implant operative notes, additional medical history, and dialysis information.The surgeon stated the hero graft was involved in the patient's death and there is no additional information available to contradict this statement.The hero graft instructions for use (ifu) specifically states: "do not place the hero graft in the same vessel as a catheter, defibrillator or pacemaker lead." the ifu also states: "use of the hero graft was clinically studied in the internal jugular vein (ijv).Implantation of the device in other vasculature has not been studied and may increase the risk of adverse events not encountered in the clinical trial." the root cause for the heart attack is unknown; however, since the patient was known to require an icd, it can be assumed that they were at a high risk for cardiac-related death.Additionally, the surgeon stated that the hero graft was not related to the patient's death.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.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.

Event Description

According to the initial report, the following were indicated: the surgeon reported the use of the hero graft with the venous outflow component in a subclavian vein with icd (implantable cardioverter defibrillator) lines.This was done in order to preserve the vessel (before it occluded) for vascular access.Mark yosick, associate director vascular technologies,instructed the surgeon that this use of the hero graft was not approved in the instructions for use.Specifically, it says "do not place the hero graft in the same vessel as a catheter, defibrillator or pacemaker lead." the surgeon reported that one patient died of heart attack after 1 year with the hero graft, and the death was not related to the hero graft.Correspondence from the hospital representative stated "the cases he spoke of happened to have had hero's but they were not involved with any of the patients problems.He does not care to participate in the investigation and provide his patient information since your product was not involved in the patient care and subsequent issues." this complaint investigation will be evaluate both hero 1001 and 1002 components, but the report will be submitted under hero 1001.

Manufacturer Narrative

According to the initial report, the following were indicated: the surgeon reported the use of the hero graft with the venous outflow component in a subclavian vein with icd (implantable cardioverter defibrillator) lines.This was done in order to preserve the vessel (before it occluded) for vascular access.(b)(6), associate director vascular technologies,instructed the surgeon that this use of the hero graft was not approved in the instructions for use.Specifically, it says "do not place the hero graft in the same vessel as a catheter, defibrillator or pacemaker lead." the surgeon reported that one patient died of heart attack after 1 year with the hero graft, and the death was not related to the hero graft.Correspondence from the hospital representative stated "the cases he spoke of happened to have had hero's but they were not involved with any of the patients problems.He does not care to participate in the investigation and provide his patient information since your product was not involved in the patient care and subsequent issues." this complaint investigation will evaluate both hero 1001 and 1002 components, but the report will be submitted under hero 1001.A request for information email was sent to the surgeon on 11/03/2015 requesting the following information: lot numbers, date of implant, date of death, pertinent comorbidities, and progress/operative notes.The surgeon replied on 11/05/2015 stating "that's a lot of information to gather.Neither myself or the hospital consider this an adverse event" and instructed further queries be made to the hospital risk manager.The email chain was forwarded to the risk manager on 11/17/2015 and a response was received on 11/19/2015.She stated the following: "i have met with [the surgeon] and he states that he has never had a case that involved a problem, infection, malfunction or any other problems related to the hero.The cases he spoke of happened to have had hero's but they were not involved with any of the patients problems.He does not care to participate in the investigation and provide his patient information since your product was not involved in the patient care and subsequent issues." manufacturing records were not reviewed as date of implant and lot numbers are unknown.The patient's date of hero graft implant is unknown; however, the patient had the hero graft approximately one year before death.This case is one of four performed by the surgeon using the hero graft with the venous outflow component (voc) in a subclavian vein with icd lines.The surgeon chose this implant approach to preserve the vessel before it occluded and stated that the vein was "big enough to accommodate the voc and the icd lines in all the cases." the only additional information on this patient was that the patient "died of a heart attack after 1 year with the hero graft." the risk management contact for this case reiterated the surgeon's opinion that the four aforementioned cases "happened to have had hero's but they were not involved with any of the patients problems." the following information is not currently available: implant operative notes, additional medical history, and dialysis information.The surgeon stated the hero graft was involved in the patient's death and there is no additional information available to contradict this statement.The hero graft instructions for use (ifu) specifically states: "do not place the hero graft in the same vessel as a catheter, defibrillator or pacemaker lead." the ifu also states: "use of the hero graft was clinically studied in the internal jugular vein (ijv).Implantation of the device in other vasculature has not been studied and may increase the risk of adverse events not encountered in the clinical trial." the ifu also lists the following complications with the use of the hero graft: myocardial infarction and death.The root cause for the heart attack is unknown; however, since the patient was known to require an icd, it can be assumed that they were at a high risk for cardiac-related death.Additionally, the surgeon stated that the hero graft was not related to the patient's death.

Event Description

According to the initial report, the following were indicated: the surgeon reported the use of the hero graft with the venous outflow component in a subclavian vein with icd (implantable cardioverter defibrillator) lines.This was done in order to preserve the vessel (before it occluded) for vascular access.(b)(6), associate director vascular technologies, instructed the surgeon that this use of the hero graft was not approved in the instructions for use.Specifically, it says "do not place the hero graft in the same vessel as a catheter, defibrillator or pacemaker lead." the surgeon reported that one patient died of heart attack after 1 year with the hero graft, and the death was not related to the hero graft.Correspondence from the hospital representative stated "the cases he spoke of happened to have had hero's but they were not involved with any of the patients problems.He does not care to participate in the investigation and provide his patient information since your product was not involved in the patient care and subsequent issues." this complaint investigation will be evaluate both hero 1001 and 1002 components, but the report will be submitted 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: 5387823
• MDR Text Key: 83889533
• Report Number: 1063481-2015-00349
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/25/2016; 01/26/2016
• 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): Death