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

Model Number	M00565120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact weight is unknown; however it was reported that the patient's body mass index is 27.68 kg/m2.(b)(4).The complainant indicated that the fragment was disposed of and the stent remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on january 10, 2020 that a wallflex colonic stent has been implanted in the colon to treat an extrinsic severe stenosis measuring 1 cm in length x 7 mm in diameter located at 30 cm proximal to the anus during a gastrointestinal stent placement procedure performed on (b)(6) 2019.According to the complainant, post stent placement, the physician noticed that a part of the delivery catheter was sheared off and was left inside the stent lumen.The fragment was successfully removed with biopsy forceps and the stent remains implanted.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 9656112
• Report Number: 3005099803-2020-00220
• Device Sequence Number: 2422653
• Product Code: MQR
• UDI-Device Identifier: 08714729456599
• UDI-Public: 08714729456599
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/31/2020

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 Expiration Date: 10/08/2020
• Device Model Number: M00565120
• Device Catalogue Number: 6512
• Device Lot Number: 0022766941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/31/2020
• 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
• Patient Age: 82 YR