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

Model Number	M00565030
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	11/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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) 2021 that a wallflex duodenal stent was implanted to treat an approximately 9 cm malignant intestinal stenosis during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous prior to stent placement.On (b)(6) 2021, post stent placement, the patient presented with vomiting.Computed tomography (ct) scan was performed and confirmed the stent migrated.The stent was removed from the patient using gastroscope and the procedure was completed another wallflex duodenal stent.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on november 26, 2021 that a wallflex duodenal stent was implanted to treat an approximately 9 cm malignant intestinal stenosis during a stent placement procedure performed on november 25, 2021.Reportedly, the patient's anatomy was not tortuous prior to stent placement.On (b)(6) 2021, post stent placement, the patient presented with vomiting.Computed tomography (ct) scan was performed and confirmed the stent migrated.The stent was removed from the patient using gastroscope and the procedure was completed another wallflex duodenal stent.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: medical device problem code a010402 captures the reportable event of stent migration.Impact code f2301 captures the additional intervention of stent replacement.Block h10: a wallflex duodenal stent was received for analysis; the delivery system was not returned.Visual examination and media inspection found no damages to the stent.The reported event of stent migration and vomiting could not be confirmed; the events occurred during the procedure and therefore could not be functionally or visually verified in the laboratory of analysis.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Additionally, stent migration is a known potential complication associated with the use of the device.Stent migration is known and documented in the labeling; therefore, the most probable root cause is known inherent risk of device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: WALLFLEX DUODENAL
• Common Device Name: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13025370
• Report Number: 3005099803-2021-07822
• Device Sequence Number: 13926642
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 10/07/2022
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0026145762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male