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

Model Number HERO 1002

Device Problem Insufficient Information (3190)

Patient Problems Rupture (2208); Pseudoaneurysm (2605)

Event Date 09/12/2014

Event Type  Injury  

Event Description

Hero graft implanted in (b)(6) 2012.The patient developed pseudo aneurysm which ruptured the graft.Per facility administrator patient had surgery to remove and repair access.Additional information was received.The operative notes state "there was a ruptured pseudoaneurysm which was not actively bleeding.The graft was dissected free from surrounding tissue and transected.Several thrombosed pseudoaneurysms were encountered." a surgical revision was performed on the graft portion.The patient currently has a perma catheter until the new graft incorporates.

Manufacturer Narrative

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

Manufacturer Narrative

The patient developed pseudo aneurysm which ruptured the graft after being implanted for over two year.Per facility administrator, patient had surgery to remove and repair access.Additional information was received including the operative notes from the hospital.The operative notes state "there was a ruptured pseudo aneurysm which was not actively bleeding.The graft was dissected free from surrounding tissue and transected.Several thrombosed pseudo aneurysms were encountered." a surgical revision was performed on the graft portion.The patient currently has a perma catheter until the new graft incorporates.The manufacturing records for lot 0001633 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.Pseudo aneurysm is listed as a potential vascular graft complication in the hero graft instructions for use (ifu).The hero graft ifu also states "rotation of cannulation sites is needed to avoid pseudo aneurysm formation." it should be noted that this patient's original implant on (b)(6) 2012 was more than two years prior to the report of surgical revision due to pseudo aneurysm on (b)(6) 2014.According to the manufacturer typically (ptfe) grafts last 1-2 years before indications of failure are noted.Therefore this eptfe graft material was likely at the end of its normal life expectancy.

Event Description

Hero graft implanted in (b)(6) 2012.The patient developed psuedo aneurysm which ruptured the graft.Per facility administrator patient had surgery to remove and repair access.Additional information was received.The operative notes state "there was a ruptured pseudoaneurysm which was not actively bleeding.The graft was dissected free from surrounding tissue and transected.Several thrombosed pseudoaneurysms were encountered." a surgical revision was performed on the graft portion.The patient currently has a perma catheter until the new graft incorporates.

Manufacturer Narrative

Hero graft implanted in (b)(6) 2012.The patient developed pseudo aneurysm which ruptured the graft.Per facility administrator patient had surgery to remove and repair access.Additional information was received.The operative notes state "there was a ruptured pseudoaneurysm which was not actively bleeding.The graft was dissected free from surrounding tissue and transected.Several thrombosed pseudoaneurysms were encountered." a surgical revision was performed on the graft portion.The op-report indicates a "presumed infection".A surgical revision was performed on the graft portion.The patient currently has a permacatheter until the new graft incorporates.The manufacturing records for lot 0001633 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.Pseudo aneurysm is listed as a potential vascular graft complication in the hero graft instructions for use (ifu).The hero graft ifu also states "rotation of cannulation sites is needed to avoid pseudo aneurysm formation." it should be noted that this patient's original implant on (b)(6) 2012 was more than two years prior to the report of surgical revision due to pseudo aneurysm on (b)(6) 2014.According to the manufacturer typically (ptfe) grafts last 1-2 years before indications of failure are noted.Therefore this eptfe graft material was likely at the end of its normal life expectancy.Given the presumed infection occurred two years after implant, it is unlikely that the infection is directly related to the hero graft.

Event Description

Hero graft implanted in (b)(6) 2012.The patient developed pseudo aneurysm which ruptured the graft.Per facility administrator patient had surgery to remove and repair access.Additional information was received.The operative notes state "there was a ruptured pseudoaneurysm which was not actively bleeding.The graft was dissected free from surrounding tissue and transected.Several thrombosed pseudoaneurysms were encountered." a surgical revision was performed on the graft portion.The op-report indicates a "presumed infection".A surgical revision was performed on the graft portion.The patient currently has a permacatheter until the new graft incorporates.

• 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: 4136771
• MDR Text Key: 15805560
• Report Number: 3006945290-2014-00075
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/12/2014

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: 0001633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 10/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/18/2014; 04/02/2015
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 55 YR