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

Catalog Number BXA082902E

Device Problems Difficult to Insert (1316); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information was requested from the physician in regards to the event.The provided information is captured in the event description.Pictures of the discarded device were requested from the physician.He replied, that no pictures of the device are 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

The patient underwent a 4-fold fenestrated endovascular aortic aneurysm repair procedure.It was planned to use a gore® viabahn® vbx balloon expandable endoprosthesis as a branch device to a renal artery.The vessels were not described as tortuous or stenosed.A 7fr flexor® ansel guiding sheath (cook medical, reference part number kcfw-7.0-35-55-rb-hfanl1-hc) was used as a guiding sheath.Both medical devices were prepared according to their instructions for use.The physician reported to gore, that he felt friction right from the beginning during advancement of the device through the guiding sheath.He reported, that the friction increased during further advancement.He could not push the device all the way through the guiding sheath.Reportedly the guiding sheath was not kinked.The physician suspected that the guiding sheath was to narrow.There was too little space between the vbx stent and the guiding sheath.Therefore he decided to withdraw the device from the patient.Reportedly, the vbx stent dislodged from the delivery catheter inside the guiding sheath during retraction.The physician then withdrew vbx stent, delivery catheter and guiding sheath from the patient in a tandem.To complete branching of the renal artery a new guiding sheath was inserted and an advanta v12 stent (getinge) was used.The physician reported that the patient is doing well.He stated that the surgery was prolonged due to the sheath replacement by 15 min.

Manufacturer Narrative

H6: code 213: a review of the manufacturing records indicated the device met pre-release specifications.B4: corrected typo in description.

Event Description

The patient underwent a 4-fold fenestrated endovascular aortic aneurysm repair procedure.It was planned to use a gore® viabahn® vbx balloon expandable endoprosthesis as a branch device to a renal artery.The vessels were not described as tortuous or stenosed.A 7fr flexor® ansel guiding sheath (cook medical, reference part number kcfw-7.0-35-55-rb-hfanl1-hc) was used as a guiding sheath.Both medical devices were prepared according to their instructions for use.The physician reported to gore, that he felt friction right from the beginning during advancement of the device through the guiding sheath.He reported, that the friction increased during further advancement.He could not push the device all the way through the guiding sheath.Reportedly the guiding sheath was not kinked.The physician suspected that the guiding sheath was to narrow.There was too little space between the vbx stent and the guiding sheath.Therefore he decided to withdraw the device from the patient.Reportedly, the vbx stent dislodged from the delivery catheter inside the guiding sheath during retraction.The physician then withdrew vbx stent, delivery catheter and guiding sheath from the patient in tandem.To complete branching of the renal artery a new guiding sheath was inserted and an advanta v12 stent (getinge) was used.The physician reported that the patient is doing well.He stated that the surgery was prolonged due to the sheath replacement by 15 min.

Event Description

The patient underwent a 4-fold fenestrated endovascular aortic aneurysm repair procedure.It was planned to use a gore® viabahn® vbx balloon expandable endoprosthesis as a branch device to a renal artery.The vessels were not described as tortuous or stenosed.A 7fr flexor® ansel guiding sheath (cook medical, reference part number kcfw-7.0-35-55-rb-hfanl1-hc) was used as a guiding sheath.Both medical devices were prepared according to their instructions for use.The physician reported to gore, that he felt friction right from the beginning during advancement of the device through the guiding sheath.He reported, that the friction increased during further advancement.He could not push the device all the way through the guiding sheath.Reportedly the guiding sheath was not kinked.The physician suspected that the guiding sheath was to narrow.There was too little space between the vbx stent and the guiding sheath.Therefore he decided to withdraw the device from the patient.Reportedly, the vbx stent dislodged from the delivery catheter inside the guiding sheath during retraction.The physician then withdrew vbx stent, delivery catheter and guiding sheath from the patient as a unit.To complete branching of the renal artery a new guiding sheath was inserted and an advanta v12 stent (getinge) was used.The physician reported that the patient is doing well.He stated that the surgery was prolonged due to the sheath replacement by 15 min.

Manufacturer Narrative

Section b4: updated the event description to align with the terms used in the instructions for use.Conclusion: neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.The cause of the reported primary failure mode of difficulty or inability to insert endoprosthesis through the introducer sheath could not be established with the information provided.As a result of the failure to advance the vbx device through the introducer sheath the device was withdrawn.As reported in the complaint description, the endoprosthesis of the vbx device came off the delivery catheter within the sheath during withdrawal.The cause of the reported secondary failure mode of endoprosthesis loses retention to the delivery system could not be confirmed with the information provided but is consistent with a reasonably foreseeable misuse.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu) recommends that if excessive resistance is felt, the delivery catheter and sheath be removed together as a unit.In the complaint description it was reported that the physician felt friction from the beginning of advancement, with friction increasing during further advancement through the sheath.When the vbx device could not be advanced any further the device was withdrawn.Although the vbx device & sheath were eventually removed as a unit, this action was taken after the endoprosthesis had already dislodged from the vbx device during the initial withdrawal attempt.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13838997
• MDR Text Key: 290549861
• Report Number: 2017233-2022-02816
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA082902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male