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

Model Number	M00565100
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (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 or Problem Description
It was reported to boston scientific corporation on november 22, 2019 that a wallflex colonic stent was to be used to treat a malignant obstruction in the colon during a stenting procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, the guidewire was advanced through the stenosis.The physician was about to advance the stent to cross the stenosis with the help of the guidewire; however, the guidewire could only advance a small part of the guidewire lumen in the stent.The guidewire and the stent was removed together from the patient and it was noted that the metal stent was visibly kinked.Another wallflex colonic stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: problem code 2976 captures the reportable event of stent kinked.Block h10: a wallflex colonic stent and delivery system were received for analysis.The stent was received not deployed and was fully covered by the outer sheath.Visual examination of the returned device found that the stainless steel tube was kinked.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received; however, the stent was deployed manually by gripping the outer sheath and pulling the tip distally.The stent was measured to be within specifications.No other issues with the stent and delivery system were noted.Taking all available information into consideration, the investigation concluded that the reported event and the observed failure are likely due to anatomical and procedural factors such as lesion characteristics, handling of the device, the technique used by the user, and normal procedural difficulties encountered during the procedure, which limited the performance of the device.Therefore, the most probable root cause is adverse event related to the 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.
Event or Problem Description
It was reported to boston scientific corporation on november 22, 2019 that a wallflex colonic stent was to be used to treat a malignant obstruction in the colon during a stenting procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, the guidewire was advanced through the stenosis.The physician was about to advance the stent to cross the stenosis with the help of the guidewire; however, the guidewire could only advance a small part of the guidewire lumen in the stent.The guidewire and the stent was removed together from the patient and it was noted that the metal stent was visibly kinked.Another wallflex colonic stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 9461500
• Report Number: 3005099803-2019-05974
• Device Sequence Number: 11532486
• Product Code: MQR
• UDI-Device Identifier: 08714729456575
• UDI-Public: 08714729456575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2020
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 0023030396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 82