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

Model Number M00565030

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

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

Event Date 07/14/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on july 18, 2022 that a wallflex duodenal stent was to be implanted to treat an approximately 5 cm malignant stricture in the duodenum during an esophagogastroduodenoscopy (egd) with duodenal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous prior to stent placement.During the procedure, the wallflex duodenal stent was deployed in the correct location.During removal of the wallflex duodenal delivery system, the delivery system got caught on the wallflex duodenal stent.As the physician continued to withdraw the delivery system, the delivery system pulled the wallflex duodenal stent and eventually the wallflex duodenal stent moved out of place.The wallflex duodenal stent was removed from the patient with rat- tooth grasping forceps and a 22 x 90 wallflex duodenal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).The complainant indicated that the wallflex duodenal stent was disposed and will not be returned for evaluation; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 15186628
• MDR Text Key: 297494464
• Report Number: 3005099803-2022-04294
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0027741039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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 Outcome(s): Required Intervention