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

Model Number	M00565090
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was approximated to be (b)(6) 2019 as no specific event date was reported.The complainant was unable to report the suspect device lot number; therefore, the manufacture and expiration dates are unknown.However, it was reported that the device was not used past its expiry date.(b)(4).According to the complainant, the suspect device remains implanted and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on august 22, 2019 that a wallflex colonic stent has been implanted to treat a malignant stricture in the colon during a stent placement procedure performed on an unknown date.Reportedly, the patient's anatomy was tight.According to the complainant, during the procedure, the stent catheter was inserted into the patient's colon via interventional radiology.During deployment, the physician felt something as if it was stuck and had more difficulty deploying the stent than usual but the stent was able to be deployed.An x-ray was taken and showed the stent did not fully expand.The stent remains implanted and reportedly, the physician aimed to implant a second wallflex colonic stent within the first stent to complete the procedure.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.

• 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: 9071296
• Report Number: 3005099803-2019-04466
• Device Sequence Number: 3588022
• Product Code: MQR
• UDI-Device Identifier: 08714729456568
• UDI-Public: 08714729456568
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00565090
• Device Catalogue Number: 6509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention