MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565060
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex colonic stent has been implanted to treat a malignant stricture in the descending colon during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during procedure, the stent was halfway deployed when it suddenly slipped from the delivery system and fully deployed not in the target location.Reportedly, the stent remains implanted, there was no attempted to remove the mis-deployed stent and another wallflex colonic stent was placed to complete the procedure.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex colonic stent has been implanted to treat a malignant stricture in the descending colon during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during procedure, the stent was halfway deployed when it suddenly slipped from the delivery system and fully deployed not in the target location.Reportedly, the stent remains implanted, there was no attempted to remove the misdeployed stent and another wallflex colonic stent was placed to complete the procedure.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Problem code 1484 captures the reportable event of stent prematurely deployed.Product investigation results: a wallflex colonic stent delivery system was received for analysis; the stent was not returned.Visual examination of the returned device identified a severe kink in the proximal end of the outer sheath at 3 inches from the exterior tube handle.The clear outer sheath and the inner member at the distal section were kinked.No other issues were noted on the device.The damages noted on the returned device were consistent with the application of excessive force during use.The investigation concluded that the observed failures were likely due to anatomical or procedural factors encountered during the procedure.Therefore, the most probable root 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.

• Brand Name: WALLFLEX COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7827559
• Report Number: 3005099803-2018-60096
• Device Sequence Number: 1517646
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2019
• Device Model Number: M00565060
• Device Catalogue Number: 56437
• Device Lot Number: 0020986848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 42