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

Model Number M00565030

Device Problems Entrapment of Device (1212); Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Initial reporter: dr.(b)(6).(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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex enteral stent was to be implanted to treat an 8cm malignant duodenal stenosis during a procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent did not fully deploy.The physician manipulated the sheath to attempt to fully deploy the stent.Reportedly, when the physician retracted the sheath, the stent fully deployed in the scope.The stent was removed with the scope, the scope was changed and another wallflex stent was used 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.

Event Description

It was reported to boston scientific corporation on july 31, 2020 that a wallflex enteral stent was to be implanted to treat an 8cm malignant duodenal stenosis during a procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent did not fully deploy.The physician manipulated the sheath to attempt to fully deploy the stent.Reportedly, when the physician retracted the sheath, the stent fully deployed in the scope.The stent was removed with the scope, the scope was changed and another wallflex stent was used 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 a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block e1: initial reporter: dr.(b)(6).Block h6: problem code 1484 captures the reportable event of stent prematurely deployed.Block h10: a wallflex duodenal stent was received for analysis; the delivery system was not returned.The stent was received completely deployed.Visual examination of the returned device did not find any damages or issues to the stent.The outer diameter (od) of the stent was measured and was found to be within specification.The reported event of stent premature deployment could not be confirmed; this failure occurred during the procedure and it is not possible to replicate in the laboratory of analysis.Taking all available information into consideration, the investigation concluded that the reported event was likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated during the procedure contributed to the reported events; however, there is not enough information to confirm the reported events as the stent was received completely deployed and in good condition.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.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, there is no information that this device was used in a manner inconsistent with the directions for use (dfu) / 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: 10442454
• MDR Text Key: 204038417
• Report Number: 3005099803-2020-03491
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• 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
• Report Date: 09/23/2020

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: 12/10/2021
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0024910252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1