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

Catalog Number BXA083902E

Device Problems Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919); Insufficient Information (3190)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

Patient information: the information was requested but not disclosed to gore.(b)(4).The second device involved in this event is reported with gore reference number (b)(4).The mfr report number will be provided as soon as available.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

On (b)(6) 2020, the patient underwent an endovascular repair of a massive aortic aneurysm and a big hepatic aneurysm.They decided to also reline the splenic artery with two short gore® viabahn® endoprostheses with propaten bioactive surface (viabahn device).They were deployed at the origin of the celiac trunk and flared into the aorta.Two gore® viabahn® vbx balloon expandable endoprostheses (viabahn vbx device) were used to stabilize the viabahn devices and to flair into the aorta.Reportedly the case was a success.On (b)(6) 2020, the seal between a viabahn device and a viabahn vbx device had been lost.The physician reported that the patient would have been in a prone lying position.He believes that the issue is a dislocation of these two devices when the patient has become mobile, he does not see this as a mechanical failure, no migration of the devices occurred.Reportedly no harm has come to the patient.The patient is doing well.Anyhow, a re-intervention is required.The plan is to bridge both devices with another viabahn device.

Manufacturer Narrative

H6-code 4111: dicom imaging series have been requested but they were not provided.H6-code 4117: the device remains implanted, therefore an engineering evaluation could not be performed.The second device involved in this event is reported with gore reference number mpdcase (b)(4); mfr report #2017233-2020-01299.

Manufacturer Narrative

H6-code 4111: several requests were sent to the physician to provide dicom imaging series for investigation.H6-code 3221: dicom imaging series were not disclosed to gore.Therefore no imaging evaluation could be performed.

Manufacturer Narrative

Section d: correction of product code and common device name.Section g: correction of pma/510(k)number.

Manufacturer Narrative

Section b: updated event description.H6-code 4111: dicom imaging series have been requested but they were not provided.H6-code 213: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.

Event Description

On (b)(6) 2020, the patient underwent an endovascular repair of a massive aortic aneurysm and a big hepatic aneurysm.They decided to also reline the splenic artery with two short gore® viabahn® endoprostheses with propaten bioactive surface (viabahn device).They were deployed at the origin of the celiac trunk and flared into the aorta.Two gore® viabahn® vbx balloon expandable endoprostheses (viabahn vbx device) were used to stabilize the viabahn devices and to flair into the aorta.Reportedly the case was a success.On (b)(6) 2020, the seal between a viabahn device and a viabahn vbx device had been lost.The physician reported that the patient would have been in a prone lying position.He believes that the issue is a dislocation of these two devices when the patient has become mobile, he does not see this as a mechanical failure, no migration of the devices occurred.Reportedly no harm has come to the patient.The patient was doing well.Anyhow, a re-intervention was required.On (b)(6) 2020, this case was revised successfully.The clinician bridged the dislocation with another viabahn device.

Manufacturer Narrative

Updated coding: h6-codes 2919 and 2682: the seal between a vsx device and a vbx device had been lost.The physician stated he believes the dislocation issue of these two devices happened when the patient became mobile and moved from prone position to another position.He does not see this as a mechanical failure and no migration of the devices occurred.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10591062
• MDR Text Key: 208746442
• Report Number: 2017233-2020-01298
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: BXA083902E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization