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

Model Number	M00565030
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon 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
Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-01217 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex duodenal stent was to be implanted to treat an intestinal obstruction during a stent placement procedure performed on (b)(6) 2022.During the procedure, the stent (the subject of mfr.Report # 3005099803-2022-01217 ) did not deploy.The stent was removed from the patient fully covered by the outer sheath.After stent removal, it was noted that the stent was kinked.A second wallflex duodenal stent was used (the subject of this report); however, again the stent did not deploy and the stent was found kinked after removal.The procedure was completed with another wallflex duodenal stent.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
Block h6: medical device problem code a0406 captures the reportable event of stent kinked.Block h10: a wallflex duodenal stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was fully deployed and expanded.The outer clear sheath was kinked, the outer blue sheath was twisted and the stainless steel handle was bent.A dimensional inspection of the delivery system was performed and found to be within specification.No other issues with the stent and delivery system were noted.The damages noted to the delivery system were most likely due to procedural factors encountered during the procedure.It may be that handling and manipulation of the device, the techniques used by the user, the characteristics of the lesion and the normal procedural difficulties limited the performance of the device and contributed to outer clear sheath kinked, outer blue sheath twisted and handle bent.However, the reported event of stent failure to deploy and stent material deformation were not confirmed as the stent was returned fully deployed and no damages were noted to the stent.There was no confirmation on what the customer indicated because the stent was returned in good condition.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-01217 and # 3005099803-2022-01218 for the associated device information.It was reported to boston scientific corporation on (b)(6), 2022 that a wallflex duodenal stent was to be implanted to treat an intestinal obstruction during a stent placement procedure performed on (b)(6) 2022.During the procedure, the stent (the subject of mfr.Report # 3005099803-2022-01217 ) did not deploy.The stent was removed from the patient fully covered by the outer sheath.After stent removal, it was noted that the stent was kinked.A second wallflex duodenal stent was used (the subject of this report); however, again the stent did not deploy and the stent was found kinked after removal.The procedure was completed with another wallflex duodenal stent.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: 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: 13772345
• Report Number: 3005099803-2022-01218
• Device Sequence Number: 5008271
• 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
• 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): 04/06/2022

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: 05/07/2023
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0027270334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2021
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 69 KG