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

Model Number HERO 1001

Device Problem Occlusion Within Device (1423)

Patient Problem Stenosis (2263)

Event Date 04/24/2015

Event Type  Injury  

Event Description

According to the report, a representative from the distributor met the surgeon from (b)(6) hospital last week and they spoke about the patient implanted with hero graft at the beginning of the year ((b)(6) 2015).Patient is quite fine.He treated stenosis on venous access of the initial ptfe prosthesis.He was surprised to see a stenosis at the connector area: thrombus deposit? fibrin deposit? nothing has been detect on the arterial component.For information, patient has been treated with 2 platelet aggregation inhibitors during the 1st month post-operatively.Now, she has plavix only.To treat stenosis at the connector, he made an angioplasty at 15 bars level pressure.Residual stenosis is 30% and have no hemodynamic impact as controlled by doppler on day 1 post-op.".

Manufacturer Narrative

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

Manufacturer Narrative

According to the report, a representative from the distributor met the surgeon from (b)(6) last week and they spoke about the patient implanted with hero graft at the beginning of the year ((b)(6) 2015).Patient is quite fine.He treated stenosis on venous access of the initial ptfe prosthesis.He was surprised to see a stenosis at the connector area: thrombus deposit, fibrin deposit: nothing has been detect on the arterial component.For information, patient has been treated with 2 platelet aggregation inhibitors during the 1st month post-operatively.Now, she has plavix only.To treat stenosis at the connector, he made an angioplasty at 15 bars level pressure.Residual stenosis is 30% and have no hemodynamic impact as controlled by doppler on day 1 post-op." this medwatch is filed for product code hero 1001.However, both hero 1001 and hero 1002 were investigated.Additional information was requested via letter from dr.(b)(6), including if the area was stented or ballooned, operative notes, and information regarding patient co-morbidities.No response was received to this request.A cryolife (b)(4) representative had a telephone conversation with dr.(b)(6) and, according to the conversation, "following the balloon angioplasty of the 'stenosis' in the connector he [dr.(b)(6)] performed on, or just prior to, (b)(6) the patient has been dialyzing well.Dr.(b)(6) proposes no further interventions at this time.Should the stenosis recur in the future dr.(b)(6) will perform a thrombectomy, rather than an angioplasty." further requests were made for operative notes and patient co-morbidity information; however, all requests were unsuccessful.The manufacturing records for lots h14vc025 (voc) and h14av014 (agc) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met cryolife release specifications.A review was performed of the available information.Partial stenosis or full occlusion of prosthesis or vasculature is listed on the hero instructions for use (ifu) as a potential vascular graft and catheter complication.In this case, the surgeon chose to treat the stenosis with a balloon angioplasty, which reduced the stenosis and resulted in improved graft flow.The patient was also prescribed platelet aggregation inhibitors post operatively; patient history is unknown and cannot be factored into the risk of stenosis following implantation.From the complaint summary, it is unclear what the cause of the stenosis was, but per the surgeon's comments, it was either a thrombosis or a fibrin deposit.Although it was not confirmed, thrombosis is the most common cause of vascular access dysfunction and a potential complication listed in the hero ifu.The surgeon's comment on relieving future stenosis issues with a thrombectomy, rather than an angioplasty, would be considered the appropriate course of action.

Event Description

According to the report, a representative from the distributor met the surgeon from (b)(6) last week and they spoke about the patient implanted with hero graft at the beginning of the year ((b)(6) 2015).Patient is quite fine.He treated stenosis on venous access of the initial ptfe prosthesis.He was surprised to see a stenosis at the connector area: thrombus deposit, fibrin deposit: nothing has been detect on the arterial component.For information, patient has been treated with 2 platelet aggregation inhibitors during the 1st month post-operatively.Now, she has plavix only.To treat stenosis at the connector, he made an angioplasty at 15 bars level pressure.Residual stenosis is 30% and have no hemodynamic impact as controlled by doppler on day 1 post-op." this medwatch is filed for product code hero 1001.However, both hero 1001 and hero 1002 were investigated.

• 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: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4763587
• MDR Text Key: 5797028
• Report Number: 1063481-2015-00061
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2015

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
• Device Lot Number: H14VC025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2015
• 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): Other