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

Model Number M00565020

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant reported the stent remains implanted but the delivery system will be returned.Although expected, the device has not yet been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted in the duodenum to treat stenosis due to a malignant tumor in the antrum of the stomach during a stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure when advancing the catheter and releasing the stent, the stent did not remain in the stenosis but rather had migrated forward.In the physician's assessment the migrated stent does not affect the enteral function of the patient.Reportedly, the physician left the stent in place and another of the same device was implanted to complete the procedure.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: problem code 3009 captures the reportable event of stent positioning problem.Block h10: the returned wallflex enteral stent was analyzed, and a visual evaluation noted that the stent was not returned.The outer blue sheath was returned kinked.A functional evaluation could not be performed because the stent was deployed.No other issues with the device were noted.The reported event of stent positioning issue could not be confirmed because this event occurred during procedure and it is not possible to replicate these events in the laboratory.It was confirmed that the outer blue sheath was kinked.Most likely, factors encountered during the handling and movement of the delivery system in the patient could have caused the stent positioning issue.Handling of the device during the deployment attempt could have caused the kink observed during the product analysis.Therefore, a review and analysis of all available information indicated that the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.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 wallflex enteral duodenal stent was implanted in the duodenum to treat stenosis due to a malignant tumor in the antrum of the stomach during a stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure when advancing the catheter and releasing the stent, the stent did not remain in the stenosis but rather had migrated forward.In the physician's assessment the migrated stent does not affect the enteral function of the patient.Reportedly, the physician left the stent in place and another of the same device was implanted to complete the procedure.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.

• 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: 9713155
• MDR Text Key: 190367861
• Report Number: 3005099803-2020-00433
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2020
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0022695911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 59