MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565590

Device Problems Positioning Failure (1158); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).A wallstent enteral uncovered stent, and delivery system were received for analysis.The stent was returned fully covered and undeployed.Visual inspection was performed and it was found that the outer blue sheath was detached from the handle.The wires of the stent punctured the clear outer sheath near the leading radiopaque marker band.The length of the delivery system was measured and was found to be within specification.No other issues were noted to the stent and delivery system.The reported event of stent failure to deploy was confirmed; the stent was returned fully covered and undeployed.The investigation concluded that the reported event and the observed failures were likely due to the factors encountered during the procedure.It may be that the interaction of the device with the scope, the patient's anatomy, and the force being applied when the stent was attempted to be deployed, limited the performance of the device and contributed to the stent wire punctured the outer sheath and detachment of the outer blue sheath from the handle.The detachment of the outer blue sheath from the handle may be the cause of the stent failure to deploy.Therefore, a review and analysis of all available information indicated the most probable 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.A labeling review was performed, and from the information available, this device was used per the directions for use (dfu)/ product label.

Event Description

It was reported to boston scientific corporation that a wallstent enteral uncovered stent was to be implanted in the duodenum to treat a stenosis during a stenting procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was unable to deploy.The procedure was completed with another wallstent enteral stent.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.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the wires of the stent punctured the clear outer sheath.

• Brand Name: WALLSTENT ENTERAL ENDOPROSTHESIS
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 10535295
• MDR Text Key: 206975715
• Report Number: 3005099803-2020-03919
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729285083
• UDI-Public: 08714729285083
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2020

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: 06/05/2021
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0023910186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• 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: 57 YR
• Patient Weight: 60