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

Model Number	M00565040
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 medwatch will be filed.
Event or Problem Description
Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2019-00053 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2018 that two wallflex colonic stents were used during a colonic stenting procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and the was not dilated prior to stent placement.According to the complainant, during the procedure, the first wallflex colonic stent (the subject of this report) was "not attached to the lesion", and the delivery system was difficult to remove.Reportedly, the stent came out along with the delivery system during catheter removal.A second wallflex colonic stent ( the subject of mfr.Report # 3005099803-2019-00053) was used but the same thing occurred.The procedure was completed with another wallflex colonic stent.There were no patient complications reported as a result of this event.Note: a photo of the complaint device showed a fully deployed stent.
Additional Manufacturer Narrative
H6: problem code 1528 captures the reportable event of delivery system difficult to remove.H10: a fully deployed wallflex colonic stent and a delivery system were returned for analysis.Visual examination of the returned device did not find any damages or issues to the stent and delivery system.The stent was measured to be within specifications.  the investigation concluded that the reported event was likely due to anatomical or procedural factors such as characteristics of the lesion, handling of the device, the techniques used by the user, and normal procedural difficulties encountered during the procedure may have 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
Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2019-00053 for the associated device information.It was reported to boston scientific corporation on december 16, 2018 that two wallflex colonic stents were used during a colonic stenting procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and the was not dilated prior to stent placement.According to the complainant, during the procedure, the first wallflex colonic stent (the subject of this report) was "not attached to the lesion", and the delivery system was difficult to remove.Reportedly, the stent came out along with the delivery system during catheter removal.A second wallflex colonic stent ( the subject of mfr.Report # 3005099803-2019-00053) was used but the same thing occurred.The procedure was completed with another wallflex colonic stent.There were no patient complications reported as a result of this event.Note: a photo of the complaint device showed a fully deployed stent.

• 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: 8237287
• Report Number: 3005099803-2019-00052
• Device Sequence Number: 19237752
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: 08714729456513
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/21/2019

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: 08/16/2019
• Device Model Number: M00565040
• Device Catalogue Number: 6504
• Device Lot Number: 0021015848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 12/16/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1