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

Model Number	M00569660
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallstent biliary rx uncovered stent was to be used in the biliary to treat cholangiocarcinoma during a stenting procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was able to be deployed; however, the stent failed to fully expand after ten minutes causing the 8 cm stent to be elongated to almost 12 cm.The stent was removed with a snare and another wallstent biliary stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Event has been updated with additional information received on august 22, 2019.Initial reporter's city, state/province, zip code: (b)(6).Problem code 3270 captures the reportable event of stent failed to expand.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.The complainant indicated that the device was disposed in accordance with the hospital protocols and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on july 14, 2019 that a wallstent biliary rx uncovered stent was to be used in the biliary to treat cholangiocarcinoma during a stenting procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was able to be deployed; however, the stent failed to fully expand after ten minutes causing the 8 cm stent to be elongated to almost 12 cm.The stent was removed with a snare and another wallstent biliary stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on august 22, 2019*** according to the complainant, the wallstent biliary rx uncovered stent was used to treat a 4-cm biliary stricture due to cholangiocarcinoma.Reportedly, the patient's anatomy was not tortuous but tight and was not dilated prior to stent placement.

• Brand Name: WALLSTENT RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8864319
• Report Number: 3005099803-2019-03809
• Device Sequence Number: 2536926
• Product Code: FGE
• UDI-Device Identifier: 08714729296867
• UDI-Public: 08714729296867
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K012752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 07/03/2019
• Device Model Number: M00569660
• Device Catalogue Number: 6966
• Device Lot Number: 0021555601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/11/2019
• 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: 70 YR