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

Model Number M00565020

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A wallflex enteral duodenal stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection found the inner and outer sheath detached from the handle.The outer sheath was accordioned in different sections.The outer clear sheath was pushed out of the inner sheath.The stainless steel (handle) was bent.No other issues were noted to the stent and delivery system.The investigation concluded that the procedural factors such as lesion characteristics, handling of the device, the technique used by the physician, and the normal procedural difficulties encountered during the procedural could have limited the performance of the device and contributed to the observed problems of inner and outer sheath detached from the handle, outer sheath accordioned, outer clear sheath pushed out of inner sheath, and the stainless-steel bent.The reported event of handle break was confirmed; however, the reported event of stent partially deployed was not confirmed as the stent was received fully covered and undeployed.There is no indication of what the customer reported because the stent was returned completely deployed.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex enteral duodenal stent was used in the duodenum to treat a 7cm malignant extrinsic stenosis during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was unable to deploy even after several attempts and the handle consequently got broken.The stent was partially deployed on the delivery system when it was removed from the patient.The procedure was completed with another wallflex enteral stent.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the inner sheath of the wallflex enteral stent was detached.

• Brand Name: WALLFLEX DUODENAL
• Type of Device: 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: 15941257
• MDR Text Key: 308256540
• Report Number: 3005099803-2022-07286
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0028468119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1