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

Model Number M00565090

Device Problems Difficult or Delayed Positioning (1157); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

Event Type  Injury  

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 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
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9071296
• MDR Text Key: 158775153
• Report Number: 3005099803-2019-04466
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456568
• UDI-Public: 08714729456568
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: M00565090
• Device Catalogue Number: 6509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention