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

Model Number M00565030

Device Problems Positioning Failure (1158); Failure to Advance (2524); Material Integrity Problem (2978)

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

Event Date 06/04/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex duodenal stent was to be implanted to treat a 6-8cm malignant gastric outlet obstruction (goo) in the duodenum during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and tight.During the procedure, resistance was felt when the device was advanced through the stricture and the tip of the stent catheter got bent.Consequently, the stent was unable to deploy and was fully covered on the delivery system when it was removed from the patient.Dilatation was performed and another wallflex duodenal stent was implanted to complete the procedure.Furthermore, the physician sent the patient for a gastrojejunostomy procedure due to a very tight stricture in the gastric outlet.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.

Event Description

It was reported to boston scientific corporation on june 04, 2022 that a wallflex duodenal stent was to be implanted to treat a 6-8cm malignant gastric outlet obstruction (goo) in the duodenum during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and tight.During the procedure, resistance was felt when the device was advanced through the stricture and the tip of the stent catheter got bent.Consequently, the stent was unable to deploy and was fully covered on the delivery system when it was removed from the patient.Dilatation was performed and another wallflex duodenal stent was implanted to complete the procedure.Furthermore, the physician sent the patient for a gastrojejunostomy procedure due to a very tight stricture in the gastric outlet.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.

Manufacturer Narrative

Block h6: medical device problem code a04 captures the reportable event of stent tip catheter bent.Block h10: a wallflex enteral duodenal stent and delivery system were returned for analysis.Visual inspection found the handle bent.The outer blue sheath was bent, and the outer clear sheath was kinked.The tip was inspected, and no damages were found.During functional inspection, the stent was unable to deploy as the handle was bent.The outer diameter of the delivery system was measured to be within specifications.No other issues with the stent and delivery system were noted.Product analysis confirmed the reported event of stent failure to deploy.However, the reported event of tip damaged/defective was not confirmed as no damages were found on the tip.Lastly, the reported event of delivery system difficult to cross lesion could not be confirmed as this occurred during the procedure and could not be functionally/visually verified.It is likely that the manipulation of the handle during the procedure limited the performance of the device and contributed to the observed events of handle bent, outer blue sheath and outer clear sheath kinked.Demonstrating excessive force during handling or usage and forcing the device against significant resistance could result in device damage or loss of functionality.Therefore, review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used in accordance with the directions for use (dfu) / product label.

• 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: 14879303
• MDR Text Key: 303247975
• Report Number: 3005099803-2022-03594
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2023
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0028267201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 55 KG