MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Jaundice (2187)
Date of Event	09/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex biliary rx covered stent was implanted to treat a stenosis in the hepatic portal during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.According to the complainant, on (b)(6) 2018, the patient presented with high bilirubin level which prompted the physician to check the stent placement.An ercp was performed and found that the stent was displaced.On (b)(6) 2018, the stent was removed with snare and another wallflex biliary stent was placed to complete the procedure.There were no patient complications reported as a result of this event.Reportedly, the stricture had resolved when the stent migrated.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex biliary rx covered stent was implanted to treat a stenosis in the hepatic portal during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.According to the complainant, on (b)(6) 2018, the patient presented with high bilirubin level which prompted the physician to check the stent placement.An ercp was performed and found that the stent was displaced.On (b)(6) 2018, the stent was removed with snare and another wallflex biliary stent was placed to complete the procedure.There were no patient complications reported as a result of this event.Reportedly, the stricture had resolved when the stent migrated.
Additional Manufacturer Narrative
(b)(4).A deployed wallflex biliary rx covered stent was received for analysis; the delivery system was not returned.Visual examination of the returned device identified no issues with the stent.The stent was measured to be within specifications.According to the complainant, the stricture was resolved at the time of the stent migration.Stricture resolution may have resulted in the stent migration.A labeling review was performed, and from the information available, this device was used per the directions for use (dfu)/product label.Additionally, stent migration is noted within the dfu as a potential adverse event related to the use of the device; therefore the most probable root cause is "known inherent risk of device" a review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8026132
• Report Number: 3005099803-2018-61143
• Device Sequence Number: 16486133
• Product Code: FGE
• UDI-Device Identifier: 08714729764922
• UDI-Public: 08714729764922
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2020
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 0021581637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 150