MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBH091002A

Device Problems Detachment Of Device Component (1104); Unintended Collision (1429); Inadequacy of Device Shape and/or Size (1583); Failure to Advance (2524); Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 09/10/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient underwent attempted treatment of a thoracic aortic aneurysm.It was reported the thoracic aorta was very tortuous consisting of four bends.It was also reported the patient had previously underwent treatment of an abdominal aortic aneurysm, and cook zenith® devices were implanted in the suprarenal aorta.An attempt was made to advance a 24 fr gore® dryseal sheath, but the sheath would not advance reportedly due to the patient¿s small access vessels (6.5¿7 mm).It was reported that after the sheath dilator was able to be inserted up to the limb of the zenith system, a conformable gore® tag® thoracic endoprosthesis was advanced without a sheath (barebacked).However, the device would not advance past the limb of the zenith system in the right common iliac artery.The gore® tag® device was removed from the patient, and a decision was reportedly made to cover the right external iliac artery with an iliac extender component and gore® viabahn endoprosthesis as a conduit.Both devices were reportedly ballooned with a 9 mm balloon for intentional contained rupture.The vessel reportedly stretched during ballooning but did not rupture.It was reported the gore® tag® device was then barebacked through the conduit, but the tag caught on the proximal bare metal portion of the zenith device.During reported multiple attempts to advance and manipulate the tag past the zenith device, the patient¿s blood pressure dropped and bleeding was reportedly noted from the right external iliac artery.It was reported the iliac extender component had become separated (amount unknown) from the viabahn during the forceful advancement of the tag, and the right external iliac artery had ruptured.It is reportedly unknown exactly when the rupture occurred.At that point, the tag was removed from the patient, and a second gore® viabahn® endoprosthesis was implanted as a bridge between the iliac extender and first viabahn to cover the rupture.It was reported the second viabahn was ballooned multiple times and a complete contained rupture was achieved as reportedly intended.The physician then barebacked the tag and was able to get the device past the zenith system and two of the bends in the thoracic aorta.It was reported that while the physician was attempting to advance the tag past the third bend in the thoracic aorta, the patient¿s blood pressure again dropped.It was reportedly determined the second gore® viabahn had moved proximally (amount unknown) due to the excessive torquing on the tag catheter during advancement, causing a separation between the iliac extender and viabahn devices.It was reported an occlusion balloon was advanced, the tag was removed, and a third gore® viabahn® endoprosthesis was implanted as a bridge between the previously placed devices in the iliac artery to cover the rupture.The device was then ballooned, and hemostasis was reportedly achieved with no bleeding noted.It was reported the physician was then able to bareback the tag past the zenith device, but the tag reportedly would not traverse past the third bend in the thoracic aorta.At that point, the physician elected to abort the procedure, and the tag was removed from the patient.It was reported the patient received 2 units of blood during the procedure due to the blood loss (amount unknown) from the rupture.There were reportedly no other clinical complications from the rupture other than the two episodes of hypotension.It was reported the patient left the operating room in stable condition.No further adverse events were reported.

Manufacturer Narrative

Brand name: medical devices - 24 fr gore® dryseal sheath, conformable gore® tag® thoracic endoprosthesis, iliac extender component, 9 mm balloon, gore® viabahn endoprosthesis (lot 12750861), gore® viabahn endoprosthesis (lot 10821557).Patient medications - aspirin, melatonin, trazodone, ranitidine, toprol, zestril, pepcid, fossamax, elavil, plavix, zyloprim, zocor, norvasc, prednisone, multivitamins, and vitamin d.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The imaging evaluation is currently in process.

Manufacturer Narrative

]results: imaging evaluation stated that the available images include a pre-implantation study.The images provided do not allow for evaluation in relation to migration or endoleak.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4152839
• MDR Text Key: 4909988
• Report Number: 2017233-2014-00517
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2017
• Device Catalogue Number: VBH091002A
• Device Lot Number: 12764893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2014
• 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): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 62