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

Model Number HERO 1001

Device Problems Kinked (1339); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 03/18/2014

Event Type  malfunction  

Event Description

According to the report, the patient is an inmate who had two arterial graft components (agc) implanted, one with a venous outflow component (voc) intact.A revision surgery was performed on tues (b)(6) 2014.At the procedure two things were noted: the voc was deep in the ventricle and the connector was too lateral.If the patient was in handcuffed in the front, the graft kinked at a 90 degree angle.The surgeon moved the existing voc back to where the tip resided in the mid-upper right atrium.He opened a new agc and trimmed the voc and connected it fully to the connector.He then trimmed the agc and anastomosed it to the existing acuseal graft.The hero was functioning as expected.The patient returned today, tues (b)(6), for a declot.This is when the surgeon discovered the voc was no longer attached to the connector.

Manufacturer Narrative

An initial review of the returned device took place on (b)(4) 2013.The return consisted of only the venous outflow component (voc).The voc was visually inspected.The voc was about 24cm long; this is about 19cm shorter than the original length.The end of the voc which would have been attached to the connector was trimmed at an angle and there appeared to be a weakening of the nitinol braiding at this end.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Manufacturer Narrative

According to a report from the field representative, the patient is a (b)(6) inmate.He had two arterial graft components (agcs) implanted, one with a venous outflow component (voc) intact.A revision surgery was performed on tuesday, (b)(6) 2014.At that procedure two things were noted: the voc was deep in the ventricle.The connector was too lateral; if the patient was handcuffed in the front, the graft kinked at a 90 degree angle.The surgeon moved the existing voc back to where the tip resided in the mid-upper right atrium.He opened a new agc and trimmed the voc and connected it fully to the connector.This was evident to the representative per the fluoroscopy images.The representative also discussed securing the voc over both barbs of the connector.The surgeon then trimmed the agc and anastomosed it to the existing acuseal graft.The hero was functioning as expected.The patient returned tuesday, (b)(6) for a declot.This is when the surgeon discovered the voc was no longer attached to the connector.Field assurance reached out to the cryolife representative in an attempt to gain a lot number from the surgeon.The surgeon indicated that he would not be able to provide a lot number because of the patient's status as an inmate.The voc was not implanted at the surgeon's hospital, and the surgeon does not know where the original implant occurred.No possible lot numbers can be identified.Operative notes were provided by the surgeon.The notes indicate two revision procedures.One revision was performed two months prior due to thrombosed hero graft in which eptfe was "thinned out" and replaced with a new hero graft connector and eptfe acuseal.The second revision was performed to relocate the voc and connector and replaced the agc.Seven days after surgery, he presented with bleeding from the clavicular surgical site, which was controlled with pressure.Later at a scheduled dialysis it was determined that the graft was non-functional and presumed clotted.The patient returned to the operating room where a clot was removed from the agc and the voc was noted to be detached from the connector.No acute bleeding was noted from the venous part or the incision for the connector.The surgeon's hospital did not have the proper equipment to perform a retrieval of the voc.The agc was ligated and dialysis access was made at the groin.The voc was later retrieved and returned to cryolife.The voc was returned to cryolife and reviewed on 04/01/2014 and 04/07/2014.The nitinol braiding at end of the voc proximal to the connector was damaged and appeared to have been crushed or clamped.The voc was approximately 19cm shorter than the original length and the end was cut at an angle.There was also a small segment of nitinol that appeared to be missing.The angled cut of the voc would increase the likelihood that the voc was not fully engaged with both barbs of the titanium connector during the second revision procedure.It is unknown how the voc was disconnected from the agc connector in the two previous revisions and if fresh cuts of the voc were made each time or if the previously cut end was twisted and pulled until dislodged from the connector which may stretch or damage the cut end.It is possible the damage noted to the proximal end of the voc was caused by blunt scissors used to cut the device or by the voc being forced back over the barbs of the connector when it became disconnected.However, the cause and/or significance of the apparent crush damage are unknown.The hero graft instructions for use describes cutting the voc: "utilizing a pair of heavy duty scissors, straight cut the voc to the desired length ensuring the cut is square to the voc." there is also a caution statement "the hero graft voc was designed to engage both barbs of the titanium connector tightly so that the pieces do not separate." there is also a photo of a correctly connected device and an incorrectly connected device with another caution: "verify the agc and voc are fully connected and that no portion of the titanium connector is exposed.".

• 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: 3724113
• MDR Text Key: 4324739
• Report Number: 3006945290-2014-00028
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2014

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?: Yes
• Device Operator: Physician
• Device Model Number: HERO 1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 04/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other