MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Catalog Number BXA077902E

Device Problem Collapse (1099)

Patient Problem No Code Available (3191)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

The physician was contacted to provided additional information, for example the lot numbers.Intra- and postprocedural images were also requested for evaluation.The device remains implanted in the patient.So no engineering evaluation could be performed.The delivery system was discarded at the facility.So no engineering evaluation could be performed.The event involves three devices reported under mfr report numbers #2017233-2020-00272 and #2017233-2020-00273.

Event Description

It was reported, that the patient underwent a covered endovascular reconstruction of aortic bifurcation (cerab) with "kissing-stent" technique in both iliac arteries using atrium advanta¿ v12 balloon expandable covered stents (getinge) some weeks ago.Control angiography imaging showed complete collapse of the advanta¿ v12 stent.It was stated, that they were almost flat.Therefore, on (b)(6) 2020, the patient underwent a reintervention to reline the collapsed advanta¿ v12 stents in both iliac arteries with three gore® viabahn® vbx balloon expandable endoprostheses (viabahn® vbx endoprostheses, sizes: 9 mm x 39 mm, 7 mm x 79 mm and 7 mm x 79 mm) using a "kissing-stent" technique.Reportedly, the physician recanalized one of the collapsed advanta¿ v12 stents and passed the others collapsed advanta¿ v12 stents subintimal to place the viabahn® vbx endoprostheses.It was stated, that a control computed tomography angiography one week post implantation showed good results.Reportedly, on (b)(6) 2020, the patient presented with pain.A computed tomography angiography showed that all three viabahn® vbx endoprostheses collapsed.It was reported, that they were almost flat.It was reported, that the patient suffered from high grade constipation.It was stated, that the physician indicated that this may result in extremely high abdominal pressure.Reportedly, the physician has said, that the collapses were not device related.Reportedly, an additional endovascular reintervention is planned to treat the collapsed viabahn® vbx endoprostheses.

Manufacturer Narrative

H6-code 50: extremely high abdominal pressure.

Manufacturer Narrative

The event involves three devices, reported under mfr report numbers #2017233-2020-00272, #2017233-2020-00273 and #2017233-2020-00274.Updated event description.Updated device information.Updated device information.Code 213: a review of the manufacturing records indicated these lots met pre-release specifications code 4111: several attempts were made to obtain additional information from the physician.The requests remain unanswered.Without additional information, gore was unable to do further investigation of this event.

Event Description

It was reported, that the patient underwent a covered endovascular reconstruction of aortic bifurcation (cerab) with "kissing-stent" technique in both iliac arteries using atrium advanta¿ v12 balloon expandable covered stents (getinge) some weeks ago.Control angiography imaging showed complete collapse of the advanta¿ v12 stent.It was stated, that they were almost flat.Therefore, on (b)(6) 2020, the patient underwent a reintervention to reline the collapsed advanta¿ v12 stents in both iliac arteries with three gore® viabahn® vbx balloon expandable endoprostheses (viabahn® vbx endoprostheses, sizes: 9 mm x 39 mm, 7 mm x 79 mm and 7 mm x 79 mm) using a "kissing-stent" technique.Reportedly, the physician recanalized one of the collapsed advanta¿ v12 stents and passed the others collapsed advanta¿ v12 stents subintimal to place the viabahn® vbx endoprostheses.It was stated, that a control computed tomography angiography one week post implantation showed good results.Reportedly, on (b)(6) 2020, the patient presented with pain.A computed tomography angiography showed that all three viabahn® vbx endoprostheses collapsed.It was reported, that they were almost flat.It was reported, that the patient suffered from high grade constipation.It was stated, that the physician indicated that this may result in extremely high abdominal pressure.Reportedly, the physician has said, that the collapses were not device related.Reportedly, an additional endovascular reintervention is planned to treat the collapsed viabahn® vbx endoprostheses.

Manufacturer Narrative

D2: corrected common device name.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9999174
• MDR Text Key: 193939227
• Report Number: 2017233-2020-00274
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/09/2020

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: Health Professional
• Device Expiration Date: 05/21/2022
• Device Catalogue Number: BXA077902E
• Device Lot Number: 20781111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/28/2020; 05/28/2020; 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR