MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Catalog Number PAH111002E

Device Problems Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problem No Code Available (3191)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device remains implanted in the patient.Requests were emailed to the physician to provide lot number, patient data, images, and further clarification of the event.

Event Description

It was reported, that a patient presented with an hepatic aneurysm, which was previously treated with a gore® viabahn® endoprosthesis with propaten bioactive surface (1 mm x 10 cm) and a gore® viabahn® vbx balloon expandable endoprosthesis (11 mm x 79 mm) overlapping each other.Reportedly, the endoprostheses have disconnected for each other, the viabahn® endoprosthesis at its distal side and the vbx endoprosthesis at its proximal side.It was stated, that a reintervention was performed where a gore® viabahn® endoprosthesis with propaten bioactive surface (13 mm x 100 mm) was used to reconnect both endoprostheses.Reportedly, the case went well and there were no further complications.

Manufacturer Narrative

H6-code 4111: additional information was provided by the physician.H6-code 4112: screenshots of patient imaging series were provided for investigation.H6-code 213: a review of the manufacturing records indicated these lots met pre-release specifications.The imaging evaluation states the following: images received via email with no patient identifier or date of acquisition in image.Images are not able to be manipulated in anyway, lengths and diameter cannot be measured with available image set.Pre re-intervention: there appears to be a separation between the proximal viabahn and the distal vbx devices.Post re-intervention: there appears to be an additional device in place, all devices appear to be patent on available images.For this event two medwatch reports where submitted, because two gore devices were involved: 2017233-2020-00198 (lot# 21242518), and 2017233-2020-00199 (lot# 21175743).

Event Description

It was reported, that the patient underwent sandostatin® treatment for thyroid cancer with liver metastases and skeletal metastases in 2015.A dilated hepatic artery was found as a coincidence.In 2018 a hepatic artery aneurysm was diagnosed which enlarged over time ((b)(6) 2019: 37 mm; (b)(6) 2019: 44 mm, (b)(6) 2019: 53 mm).On (b)(6) 2019, the aneurysm was treated with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn® endoprosthesis ), 11 mm x 10 cm, and a gore® viabahn® vbx balloon expandable endoprosthesis (viabahn® vbx endoprosthesis), 11 mm x 79 mm, overlapping each other.Access was gained via the right common femoral artery.To advance the viabahn® endoprosthesis a 12fr introducer sheath and an amplatz guide wire were used.The viabahn® endoprosthesis was placed from the trunk ostium with a small part reaching into the aorta towards the distal part of the aneurysm.To advance the viabahn® vbx endoprosthesis an 8.5fr destino¿ twist steerable guiding sheath (oscor) was used.The viabahn® vbx endoprosthesis was used to extend the viabahn® endoprosthesis towards the distal part of the aneurysm.It was stated, that the overlap zone of the endoprostheses was at least 30 mm.Both endoprosthesis extended at least 20 mm proximal and distal to the margins of the aneurysmal lesion to provide best sealing.Reportedly, the viabahn® endoprosthesis was post-dilated proximal at the ostium, the distal part of the viabahn® vbx endoprosthesis was post-dilated to 16 mm.It was reported, that, on (b)(6) 2019, one day after the procedure, the patient presented with abdominal pain.However, the patient was discharged in the morning.It was stated, that the patient presented with severe abdominal pain in the afternoon on the same day.Reportedly, a computed tomography angiography demonstrated that the viabahn® endoprosthesis and the viabahn® vbx endoprosthesis have disconnected.It was stated, that the distal part of viabahn® endoprosthesis and the proximal part of the viabahn® vbx endoprosthesis was floating in the aneurysmal sac.On (b)(6) 2019, a reintervention was performed where a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn® endoprosthesis), 13 mm x 10 cm, was used to reconnect the previously implanted endoprostheses.To implant the viabahn® endoprosthesis multiple concomitant devices were used.They started with a simmons 1 catheter and a 7fr aptus steerable sheath (medtronic).It was stated, that several attempts and different techniques were performed trying to get the guide wire into viabahn® vbx endoprosthesis.The successful technique was making a guide wire loop in the aneurysmal sack.In order to achieve this, increasingly stiffer guide wires have been used until a precurved amplatz guide wire was in place.Then they replaced the 7fr aptus steerable sheath with a 12fr flexor® introducer sheath (45 cm, cook medical) to advance the viabahn® endoprosthesis to reconnect the previously implanted endoprostheses.Reportedly, the case went well and there were no further complications.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9849398
• MDR Text Key: 192048132
• Report Number: 2017233-2020-00199
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2022
• Device Catalogue Number: PAH111002E
• Device Lot Number: 21175743
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR