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

Model Number HERO 1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Headache (1880)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the report, "the surgeon reported that he made a misjudgement in assessing the existing stenosis of the svc and implanted the hero 1001 anyway.As a result the patient suffers from headaches and the surgeon plans to stent the svc and then wants to re-implant the hero 1001.The surgeon clearly explained that he made the mistake and the graft is not to be blamed.".

Manufacturer Narrative

According to the report "the surgeon reported that he made a misjudgment in assessing the existing stenosis of the svc and implanted the hero 1001 [voc - venous outflow component] anyway.As a result the patient suffers from headaches and the surgeon plans to stent the svc and then wants to re-implant the hero 1001.The surgeon clearly explained that he made the mistake and the graft is not to be blamed." additional information was received on 12/01/2015.The lot numbers were provided as hero 1003 (b)(4) and hero 1001 (b)(4).On 02/17/2016 the lot numbers were confirmed; original implant and second implant are from the same lot.On 12/09/2015 an email was sent asking for additional information relating to how the surgeon assessed his "misjudgment" of the svc, if operative notes were available and if a revision had been planned.On 12/10/2015 an email was received stating the original implant date was (b)(6) 2015 and at that time the surgeon decided it was not necessary to dilate the svc.After implant the patient suffered headaches and a revision was planned.An email was sent to a cryolife representative from the surgeon that stated, "it is about a (b)(6) patient, transplanted three times, with multiple accesses in both upper limbs and lower limb.She has already presented a syndrome of superior vena cava during the passing of a central venous catheter, and had an angioplasty without stenting of the superior vena cava in another center.To the right pulses humeral and radial nerve are perceived, to the left only the humeral pulse is perceived, and the artery radial road was approached by multiple times.As native access, the last possibility is thus the right lower limb.That's why i think that is a good candidate in hero graft in right upper limb rather." on 12/16/2015 a translated email was forwarded that stated following the initial hero implant the patient complained of severe headaches whenever she bent forwards.The revision took place on (b)(6) 2015.The original incision in the shoulder was re-opened and lengthened slightly.The old voc was disconnected from the titanium connector and withdrawn without difficulty from the patient.The svc was then dilated by angioplasty using an armada 35 12mm x 60mm balloon.An e-luminex 14mm x 60mm open stent was then placed in the svc, followed by the placement of a second stent more distal to the heart and partially inside the first stent.The second stent was a fluency plus 13.5mm x 60mm covered stent.A new hero voc (lot # h15vc019) was placed in the svc, through the stents using the hero accessory kit (lot # h15ak005).A message from the surgeon was received on 12/03/2015 that stated the patient no longer had superior vena cava syndrome and that she had a successful double needle cannulation.The manufacturing records for the lot number was reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review of the available information was performed.The patient was implanted with a hero graft on (b)(6) 2015.Post implant the patient complained of severe headaches whenever she bent forward.The patient had a history of superior vena cava syndrome and the surgeon determined that he "made a misjudgment in assessing the existing stenosis of the svc." he "clearly explained that he made the mistake and the graft is not to be blamed." on (b)(6) 2015 the hero graft was revised.The voc was explanted and the patient's svc was dilated by angioplasty.An open stent was placed in the svc, followed by the placement of a second (placed partially inside the first stent).A new hero voc was placed in the svc, through the stents.The revision was successful and the patient no longer had headaches.The first date of cannulation was on (b)(6) 2015.On (b)(6) 2015 the patient was reported to no longer have svc syndrome.The patient's known medical history includes the following: three prior transplants, multiple failed vascular accesses, and svc syndrome.Implant and intervention notes were not provided.As previously stated, the patient had pre-existing svc syndrome and the surgeon stated that the revision and post-op symptoms were related to a technical error, given the svc syndrome.There is no indication that there was an issue with the hero graft that caused the svc symptoms reported here.It should be noted that the hero graft instructions for use (ifu) states, "caution should be used when placing or removing the venous outflow component where stent contact may occur due to the potential for venous outflow component or vessel damage." the cause of the reported headaches was voc placement in a pre-existing stenotic svc.The surgeon conceded to a technical misjudgment and surgical revision corrected the symptoms.The ifu provides the following instructions: "using ultrasound guidance, gain percutaneous access to the venous system utilizing a 5f micropuncture set and standard seldinger technique.Based upon venous anatomy, determine if serial dilation is required." the ifu lists superior vena cava syndrome as a potential complication with the use of the hero graft.

Event Description

According to the report, "the surgeon reported that he made a misjudgement in assessing the existing stenosis of the svc and implanted the hero 1001 anyway.As a result the patient suffers from headaches and the surgeon plans to stent the svc and then wants to re-implant the hero 1001.The surgeon clearly explained that he made the mistake and the graft is not to be blamed.".

Manufacturer Narrative

Correction made to date of implant to reflect (b)(6) 2015.

Event Description

According to the report, "the surgeon reported that he made a misjudgement in assessing the existing stenosis of the svc and implanted the hero 1001 anyway.As a result the patient suffers from headaches and the surgeon plans to stent the svc and then wants to re-implant the hero 1001.The surgeon clearly explained that he made the mistake and the graft is not to be blamed.".

• 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: 5312424
• MDR Text Key: 33933228
• Report Number: 1063481-2015-00360
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2015

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 Expiration Date: 07/10/2017
• Device Model Number: HERO 1001
• Device Lot Number: H15VC019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/18/2016; 03/09/2016
• 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): Other; Required Intervention
• Patient Age: 38 YR