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

Model Number M00565020

Device Problems Positioning Failure (1158); Use of Device Problem (1670); Activation Failure (3270)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not 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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation on february 18, 2021 that a wallflex duodenal stent was to be implanted during a duodenal stent placement procedure performed on (b)(6) 2021.It was reported that the stent did not open.The procedure was completed with another wallflex duodenal stent.There were no patient complications reported as a result of this event.Note boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation on (b)(6), 2021 that a wallflex duodenal stent was to be implanted during a duodenal stent placement procedure performed on (b)(6), 2021.It was reported that the stent did not open.The procedure was completed with another wallflex duodenal stent.There were no patient complications reported as a result of this event.Additional information received on (b)(6), 2021.It was reported that the stent was to be implanted to treat a 65 mm stricture in the esophagus due to stomach ulcer.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent failed to deploy.Reportedly, the stent was fully covered by the outer sheath when it was removed from the patient.Note: it was reported that the wallflex duodenal stent was to be implanted in the esophagus.However, wallflex duodenal stent system with anchor lock delivery system directions for use (dfu) states that the device is used for palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.The stent is not indicated to be implanted in the esophagus.Additional information was received that the stent failed to deploy and was fully covered by the outer sheath when removed from the patient.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.

Manufacturer Narrative

Blocks b5, d7a, e1 (initial reporter's facility name, address 1, city), g2 (report source), h6 (patient code, impact code, device codes) and h8 have been updated with additional information received on march 10, 2021 and march 11, 2021.Block e1: the initial reporter's address is (b)(6).Block h6: medical device problem code a150101 captures the reportable event of stent did not open.Block h10: the device has not 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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex duodenal stent was to be implanted during a duodenal stent placement procedure performed on (b)(6) 2021.It was reported that the stent did not open.The procedure was completed with another wallflex duodenal stent.There were no patient complications reported as a result of this event.***additional information received on (b)(6), 2021 and (b)(6), 2021*** it was reported that the stent was to be implanted to treat a 65 mm stricture in the esophagus due to stomach ulcer.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent failed to deploy.Reportedly, the stent was fully covered by the outer sheath when it was removed from the patient.Note: it was reported that the wallflex duodenal stent was to be implanted in the esophagus.However, wallflex duodenal stent system with anchor lock delivery system directions for use (dfu) states that the device is used for palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.The stent is not indicated to be implanted in the esophagus.Additional information was received that the stent failed to deploy and was fully covered by the outer sheath when removed from the patient.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.***additional information received on (b)(6), 2021*** it was reported that the wallflex duodenal stent was to be implanted to treat a gastroduodenal stenosis.

Manufacturer Narrative

Blocks b5 and h6 (device code) have been updated with additional information received on (b)(6), 2021.Block e1: the initial reporter's address is (b)(6).Block h6: medical device problem code a150101 captures the reportable event of stent did not open.Block h10: the device has not 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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6), 2021 that a wallflex duodenal stent was to be implanted during a duodenal stent placement procedure performed on (b)(6), 2021.It was reported that the stent did not open.The procedure was completed with another wallflex duodenal stent.There were no patient complications reported as a result of this event.***additional information received on (b)(6), 2021 and (b)(6), 2021*** it was reported that the stent was to be implanted to treat a 65 mm stricture in the esophagus due to stomach ulcer.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent failed to deploy.Reportedly, the stent was fully covered by the outer sheath when it was removed from the patient.Note: it was reported that the wallflex duodenal stent was to be implanted in the esophagus.However, wallflex duodenal stent system with anchor lock delivery system directions for use (dfu) states that the device is used for palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.The stent is not indicated to be implanted in the esophagus.Additional information was received that the stent failed to deploy and was fully covered by the outer sheath when removed from the patient.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.***additional information received on (b)(6), 2021*** it was reported that the wallflex duodenal stent was to be implanted to treat a gastroduodenal stenosis.

Manufacturer Narrative

Block e1: the initial reporter's address is (b)(6).Block h6: medical device problem code a150101 captures the reportable event of stent did not open.Block h10: a wallflex duodenal stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual examination of the returned device found that the outer sheath was accordioned, twisted, and detached from the handle section.No other issues were noted to the stent and delivery system.The reported event of stent failure to deploy was confirmed.It is possible that the factors encountered during the procedure and/or the patient anatomy could have caused the physician to feel resistance and limited the performance of the device, contributing to the observed failures of the outer sheath and the reported event of stent failure to deploy.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the 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 instructions for use (ifu) / 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
• MDR Report Key: 11455276
• MDR Text Key: 242041352
• Report Number: 3005099803-2021-00994
• 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: company representative,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/18/2021

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: 07/09/2022
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0025690300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 03/10/2021; 04/05/2021; 04/27/2021
• Supplement Dates FDA Received: 04/02/2021; 04/08/2021; 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR