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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pseudoaneurysm (2605)

Event Type  malfunction  

Manufacturer Narrative

Review of the manufacturing records could not be completed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.

Event Description

The following was reported to gore: on an unknown date, a biliary metallic stent (mfg unknown) was placed to treat unresectable pancreatic head cancer.The patient also received chemotherapy at that time.After treatment, the patient vomited blood frequently.Pseudoaneurysm in the proximal part of superior mesenteric artery associated with infection was observed by the doctor.To treat the pseudoaneurysm, a gore® viabahn® endoprostheses was placed and dual antiplatelet therapy (dapt) was performed.On an unknown date, a new pseudoaneurysm was observed in the distal part of the gore® viabahn® endoprostheses.Another gore® viabahn® endoprostheses was placed at that time.During placement, acute occlusion of the first gore® viabahn® endoprostheses occurred.To resolve the occlusion, thrombectomy was performed.It was confirmed that the superior mesenteric artery was patent and no ischemia was detected.One month later, ct revealed an occlusion of the gore® viabahn® endoprostheses.Moreover, air was observed inside and outside of the gore® viabahn® endoprostheses.It was confirmed that mesenteric ischemia was not present.Biliary metallic stent breakage was observed at that time.The doctor reported that the biliary metallic stent break contributed to occlusion of gore® viabahn® endoprostheses.The symptom of infection was noted but the patient was discharged from the hospital with the absence of any bleeding.Several months passed by and the patient visited the medical facility complaining about abdominal pain.Ct revealed that the gore® viabahn® endoprostheses had migrated partially into the duodenum.According to the doctor, no obvious bleeding was observed but the base of the superior mesenteric artery was embolized with n-butyl cyanoacrylate (nbca) to prevent further migration.Five days after the embolization procedure, ct revealed that the gore® viabahn® endoprostheses had disappeared.The doctor believes that the gore® viabahn® endoprostheses passed out of the body.The patient's condition is good.

Manufacturer Narrative

Corrected data: h1 - type of reportable event.

Manufacturer Narrative

Corrected data: b5 - describe event or problem.B7 - other relevant history, including preexisting medical conditions.Additional manufacturer narrative: note: there are two devices involved with this incident.Reference medwatch #2017233-2019-00483 for second device.

Event Description

The following was reported to gore: on an unknown date, a biliary metallic stent (mfg unknown) was placed to treat unresectable pancreatic head cancer.The patient also received chemotherapy at that time.After treatment, the patient vomited blood frequently.Pseudoaneurysm in the proximal part of superior mesenteric artery associated with infection was observed by the doctor.To treat the pseudoaneurysm, a gore® viabahn® endoprostheses was placed and dual antiplatelet therapy (dapt) was performed.On an unknown date, a new pseudoaneurysm was observed in the distal part of the gore® viabahn® endoprostheses.Another gore® viabahn® endoprostheses was placed at that time.During placement, acute occlusion of the two gore® viabahn® endoprostheses occurred.To resolve the occlusion, thrombectomy was performed.It was confirmed that the superior mesenteric artery was patent and no ischemia was detected.One month later, ct revealed an occlusion of both gore® viabahn® endoprostheses.Moreover, air was observed inside and outside both of the gore® viabahn® endoprostheses.It was confirmed that mesenteric ischemia was not present.Biliary metallic stent breakage was observed at that time.The doctor reported that the biliary metallic stent break contributed to occlusion of the gore® viabahn® endoprostheses.The symptom of infection was noted but the patient was discharged from the hospital with the absence of any bleeding.Several months passed by and the patient visited the medical facility complaining about abdominal pain.Ct revealed that both gore® viabahn® endoprostheses had migrated partially into the duodenum.According to the doctor, no obvious bleeding was observed but the base of the superior mesenteric artery was embolized with n-butyl cyanoacrylate (nbca) to prevent further migration.Five days after the embolization procedure, ct revealed both gore® viabahn® endoprostheses had disappeared.The doctor believes that the gore® viabahn® endoprostheses passed out of the body.The patient's condition is good.

Manufacturer Narrative

Additional manufacturer narrative: this report addresses the device migration (reportable malfunction/product problem).Medwatch 2017233-2019-00699 addresses the pseudoaneurysm, occlusion, and additional surgical procedure of this event.Corrected data: b1: adverse event and/or product problem.H1: type of reportable event.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8746409
• MDR Text Key: 151428650
• Report Number: 2017233-2019-00481
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• 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: 09/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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