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

Model Number M00565020

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2018

Event Type  Injury  

Manufacturer Narrative

Problem code captures the reportable event of stent material deformation.The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex duodenal stent was to be used to treat a 5cm malignant stricture in the superior part (d1) of the duodenum during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.However, after deployment, the stent shrunk and was pushed together when viewed endoscopically.The stent was immediately removed with forceps and another wallflex duodenal stent was placed to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).A fully deployed wallflex enteral stent and delivery system were received for analysis.Visual examination found the stent was deformed and kinked and the stent wires were broken.The proximal end of the outer sheath was found kinked and the stainless steel tube was noted to have bent.No other issues with the device were noted.Per analysis, the damages noted on the returned device were consistent with the application of force during use.Taking all available information into consideration, the investigation concluded that the observed failures and the reported event were likely due to anatomical or procedural factors encountered during the procedure, such as the nature of the stricture and the use of excessive force on the device.Additionally, the damage to the stent, including the kinked and broken wires, may have occurred during removal.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.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex duodenal stent was to be used to treat a 5cm malignant stricture in the superior part (d1) of the duodenum during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.However, after deployment, the stent shrunk and was pushed together when viewed endoscopically.The stent was immediately removed with forceps and another wallflex duodenal stent was placed to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7891683
• MDR Text Key: 120824021
• Report Number: 3005099803-2018-60453
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• Combination Product (y/n): N
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2020
• Device Model Number: M00565020
• Device Catalogue Number: 56436
• Device Lot Number: 0022312712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 10/24/2018
• Supplement Dates FDA Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention