MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00555830

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

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

Event Date 03/10/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex duodenal stent was to be implanted to treat a 1cm malignant stricture in the duodenum during a metal stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous.During the procedure, the stent was attempted to be deployed; however, the stent fully deployed in an incorrect location.The stent was removed using forceps.The procedure was completed using another wallflex duodenal stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

Block e1: initial reporter phone: (b)(6).Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Block h10: a wallfex duodenal stent and delivery system were received for analysis.Visual examination of the returned device found the stent fully deployed and coiled and the wire unraveled.The outer clear sheath was also kinked.No other issues were noted to the stent and delivery system.The investigation concluded that the observed failures of stent coiled and unraveled, and outer sheath kinked were likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, and/or the technique used by the physician, limited the performance of the device and contributed to the observed failures.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Additionally, stent misplacement is a known potential complication associated with the use of the device in the manufacturer's labeling.Taking all available information into consideration, the investigation concluded that the reported event of stent positioning issue is a known potential complication associated with the use of the device in the manufacturer's labeling.Therefore, the most probable root cause is known inherent risk of device.

Event Description

It was reported to boston scientific corporation on march 13, 2023, that a wallflex duodenal stent was to be implanted to treat a 1 cm malignant stricture in the duodenum during a metal stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous.During the procedure, the stent was attempted to be deployed; however, the stent fully deployed in an incorrect location.The stent was removed using forceps.The procedure was completed using another wallflex duodenal stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: WALLFLEX DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM
• 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: 16564893
• MDR Text Key: 311495542
• Report Number: 3005099803-2023-01406
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

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: 02/24/2024
• Device Model Number: M00555830
• Device Catalogue Number: 5583
• Device Lot Number: 0028930567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2022
• 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