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

Model Number	M00565100
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).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 was to be used to treat a malignant stenosis in the colon during a bowel stenting procedure performed on (b)(6) 2018.According to the complainant, during preparation and outside the patient, the stent wires on both ends were noted to be deformed.The procedure was completed with another wallflex colonic stent.There were no patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Problem code 2976 captures the reportable event of stent damaged.A fully constrained wallflex colonic stent and delivery system were received for analysis.Visual examination of the returned device found a kink in the stainless steel tube, and in the outer sheath at 3 inches from the exterior tube handle (proximal end).Functional evaluation revealed that the stent could not be deployed 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 and a visual inspection identified no issues.The kinks in the device are consistent with the application of excessive force on the delivery system, and may have occurred when the device was being handled during preparation.The reported event of deformed stent wire was not confirmed, however the reported event that the device was kinked near the handle was confirmed.The complainant confirmed the correct device was returned for analysis.Therefore, taking all available information into consideration, the investigation concluded that the most probable root cause is caused traced to component failure, as there was an expected or random component failure without any design or manufacturing issue.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 (b)(6) 2018 that a wallflex colonic stent was to be used to treat a malignant stenosis in the colon during a bowel stenting procedure performed on (b)(6) 2018.According to the complainant, during preparation and outside the patient, the stent wires on both ends were noted to be deformed.The procedure was completed with another wallflex colonic stent.There were no patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.Additional information received on november 14, 2018: the complainant reported that there was also a kink near the handle.

• 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: 7960419
• Report Number: 3005099803-2018-60701
• Device Sequence Number: 16564417
• 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): 12/03/2018

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: 11/30/2018
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 0020022564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1