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

Model Number HERO 1002

Device Problem Difficult To Position (1467)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 10/23/2014

Event Type  Death  

Event Description

Dr.(b)(6) had a very challenging patient with limited access options.(b)(6) placed the wire the day before surgery.Dr.(b)(6) implanted the hero graft in the patient's groin, and he felt like the case went very well.The case finished around 11:20 am.At approximately 1:20 pm, cryolife was told the patient had passed away.Dr.(b)(6) said that the patient went into cardiac arrest post-op, and he does not think that the hero graft was related or associated with the cause of death.As it is unknown if either the hero 1001 or hero 1002 component contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1002 component.

Event Description

Dr.(b)(6) had a very challenging patient with limited access options.Ir placed the wire the day before surgery.Dr.(b)(6) implanted the hero graft in the patient's groin, and he felt like the case went very well.The case finished around 11:20 am.At approximately 1:20 pm, cryolife was told the patient had passed away.Dr.(b)(6) said that the patient went into cardiac arrest post-op, and he does not think that the hero graft was related or associated with the cause of death.As it is unknown if either the hero 1001 or hero 1002 component contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1002 component.

Manufacturer Narrative

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

Manufacturer Narrative

Dr.(b)(6) had a very challenging patient with limited access options.Ir placed the wire the day before surgery.Dr.(b)(6) implanted the hero graft in the patient's groin, and he felt like the case went very well.The case finished around 11:20 am.At approximately 1:20 pm, cryolife was told the patient had passed away.Dr.(b)(6) said that the patient went into cardiac arrest post-op, and he does not think that the hero graft was related or associated with the cause of death.As it is unknown if either the hero 1001 or hero 1002 component contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1002 component.Patient medical records were provided and reviewed.According to the available information the surgeon implanted the hero graft in the patient's groin without complication.Approximately two hours after the surgery was completed the rep was informed that the patient had passed away.During a follow-up phone with the surgeon he stated he did "not think the hero graft was related or associated with cause of death." additional information was sought to further clarify the circumstances and determine if hero graft was potentially associated with the unfortunate outcome.Review of the operative report described a patient to be a (b)(6) male with numerous medical problems including end-stage renal disease, congestive heart failure, and hypertension.These conditions may predispose such a patient to a sudden cardiac event.There were no complications or issues noted or described related to implanted product.There is no alleged deficiency of the hero graft or assertion that the clinical events were related to the product.Therefore, no complaint investigation is warranted and the complaint will be voided.

• 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: 4207657
• MDR Text Key: 4985310
• Report Number: 3006945290-2014-00084
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2014

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 1002
• Device Lot Number: H14AV007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 10/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2015
• 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): Death; Other
• Patient Age: 27 YR