MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number	M00565010
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 duodenal stent has been implanted to treat a malignant stricture in the duodenum during a procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was intentionally released, but was deployed distally from the target location.Reportedly, the stent remains implanted and a different stent was placed proximally to cover the entire stricture.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).Block h10: a wallflex duodenal delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the stainless steel tube, and the outer sheath at 3 inches from the exterior tube handle were kinked.No other issues with the delivery system were noted.The noted damages on the returned device are consistent with excessive force applied during use.The investigation concluded that procedural factors as handling of the device, or the technique used by the physician, and normal procedural difficulties encountered during the procedure, could have affected the device performance and its integrity contributing to the failure reported.Therefore, the most probable root cause is adverse event related to procedure.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.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/26/2018 12:30 pm ct.The report number is being corrected from: 3005099803-2018-62167 to: 3005099803-2018-61514.
Event or Problem Description
It was reported to boston scientific corporation on november 5, 2018 that a wallflex duodenal stent has been implanted to treat a malignant stricture in the duodenum during a procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was intentionally released, but was deployed distally from the target location.Reportedly, the stent remains implanted and a different stent was placed proximally to cover the entire stricture.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX DUODENAL
• Common Device Name: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8087162
• Report Number: 3005099803-2018-61514
• Device Sequence Number: 1203538
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062750
• 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): 01/24/2019

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: 09/02/2020
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0022597824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 12/01/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1