MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565580
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
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 wallstent enteral uncovered stent was to be used to treat a malignant stricture in the duodenojejunal flexure due to pancreatic adenocarcinoma during an endoscopic stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure, the duodenal stent was positioned under radiologic and endoscopic view with the opaque markers placed at the center of the duodenal stenosis.During stent deployment, the sheath did not open properly and deployment of the stent could not be controlled.The stent was accidentally deployed distal to the duodenal stenosis.Reportedly, the physician was comfortable leaving the stent implanted and the location of the stent does not have any clinical significance.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
A wallstent enteral uncovered delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found some bends along the outer sheath.No other issues with the device were noted.The damage noted with the device was consistent with the application of excessive force during use.Taking all available information into consideration, the investigation concluded that the observed failure and the reported event were likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.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.A search of the complaint database revealed that no other similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallstent enteral uncovered stent was to be used to treat a malignant stricture in the duodenojejunal flexure due to pancreatic adenocarcinoma during an endoscopic stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure, the duodenal stent was positioned under radiologic and endoscopic view with the opaque markers placed at the center of the duodenal stenosis.During stent deployment, the sheath did not open properly and deployment of the stent could not be controlled.The stent was accidentally deployed distal to the duodenal stenosis.Reportedly, the physician was comfortable leaving the stent implanted and the location of the stent does not have any clinical significance.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.

• Brand Name: WALLSTENT¿ ENTERAL ENDOPROSTHESIS
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7529691
• Report Number: 3005099803-2018-01551
• Device Sequence Number: 11068846
• Product Code: MQR
• UDI-Device Identifier: 08714729285076
• UDI-Public: 08714729285076
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K000281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2020
• Device Model Number: M00565580
• Device Catalogue Number: 6558
• Device Lot Number: 0021830066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR