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

Model Number	M00565100
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Captures the reportable event of stent damaged.The complaint device ha 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 mechanical bowel obstruction in the colon caused by ileus cancer during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, at first the stent was easily deployed.However, when attempting to fully deploy the stent, it was unable to completely release.The stent was removed from the patient partially deployed.A photo of the stent was received and based on this, the stent was noted to be damaged at the end.The procedure was completed with another wallflex colonic stent.There were no consequences or impact to the patient as a result of this event.
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 mechanical bowel obstruction in the colon caused by ileus cancer during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, at first the stent was easily deployed.However, when attempting to fully deploy the stent, it was unable to completely release.The stent was removed from the patient partially deployed.A photo of the stent was received and based on this, the stent was noted to be damaged at the end.The procedure was completed with another wallflex colonic stent.There were no consequences or impact to the patient as a result of this event.
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).A deployed wallflex colonic stent was received for analysis; the delivery system was not returned.Visual examination found the stent was damaged; the stent was deformed, kinked and stent wires were broken.The stent was measured to be within specifications.No other issues were noted with the stent.Per analysis, the damages noted on the returned device were consistent with the application of force during use.Taking all available information into consideration, the investigation concluded that the observed failures and the reported event were likely due to anatomical or procedural factors encountered during the procedure, such as the nature of the stricture and the use of excessive force on the device.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.
Additional Manufacturer Narrative
Problem code 2976 captures the reportable event of stent damaged.A deployed wallflex colonic stent was received for analysis; the delivery system was not returned.Visual examination found the stent was damaged; the stent was deformed, kinked and stent wires were broken.The stent was measured to be within specifications.No other issues were noted with the stent.Per analysis, the damages noted on the returned device were consistent with the application of force during use.Taking all available information into consideration, the investigation concluded that the observed failures and the reported event were likely due to anatomical or procedural factors encountered during the procedure, such as the nature of the stricture and the use of excessive force on the device.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.Catalog number has been corrected.
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 mechanical bowel obstruction in the colon caused by ileus cancer during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, at first the stent was easily deployed.However, when attempting to fully deploy the stent, it was unable to completely release.The stent was removed from the patient partially deployed.A photo of the stent was received and based on this, the stent was noted to be damaged at the end.The procedure was completed with another wallflex colonic stent.There were no consequences or impact to the patient as a result of this event.

• 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: 7852788
• Report Number: 3005099803-2018-60278
• Device Sequence Number: 19148268
• Product Code: MQR
• UDI-Device Identifier: 08714729456575
• UDI-Public: 08714729456575
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 11/19/2018

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: 04/18/2019
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 0020534295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 09/26/2018; 10/23/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/19/2018; 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1