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

Model Number	M00565090
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporters facility name: (b)(6).(b)(4).A wallflex colonic stent and delivery system were returned for analysis.The stent was received partially deployed.Visual inspection was performed and found the stent was deformed.The wire of the stent was unraveled (damaged).The outer blue sheath was kinked at the proximal section and the outer clear sheath was damaged at the distal section.Functional examination was performed by sliding the handle back along with the stainless steel tube and the stent was deployed with some resistance due to the kinks noted in the outer sheath.A dimensional inspection of the stent was performed and the stent did not meet the specification.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed.Taking all available information into consideration the investigation concluded that the reported event and the observed failures were most likely due to anatomical and/or procedural factors encountered during the procedure.It is possible that when the physician attempted to deploy the stent, the stent wire was damaged and resulted in the sheath damage and stent partial deployment.It may be that the patient's tortuous anatomy could have caused the kinks noted in the outer sheath and resulted to stent partial deployment.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted to treat an intestinal obstruction caused by colon tumor during a colon stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was attempted to be deployed; however, the position of the stent deviated from the target location.The physician attempted to re-sheath the stent but was unsuccessful.The stent was removed from the patient partially deployed on the delivery system.The procedure was completed with another wallflex colonic 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 result which revealed the stent was damaged and deformed.

• 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: 12526147
• Report Number: 3005099803-2021-04977
• Device Sequence Number: 1547842
• Product Code: MQR
• UDI-Device Identifier: 08714729456568
• UDI-Public: 08714729456568
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2021
• Device Model Number: M00565090
• Device Catalogue Number: 6509
• Device Lot Number: 0024352947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 75