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

Model Number	M00565060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); No Code Available (3191)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no specific event date was reported.The complainant was unable to provide the 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).The complainant indicated that the suspect device 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on june 26, 2019 that a wallflex colonic stent has been implanted in the colon to treat an obstruction during a stent placement procedure performed on (b)(6) 2019.Reportedly, the stent was placed for decompression before a scheduled resection and the procedure went well.According to the complainant, on an unknown date, the patient presented back to the hospital with a perforated diverticulitis.There was no reported issue with the stent and it is unknown whether there is a relationship between the stent and the perforated diverticulitis.A surgery was performed but it is unknown when the surgery occurred or what it entailed.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

• 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: 8808091
• Report Number: 3005099803-2019-03621
• Device Sequence Number: 320589
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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: M00565060
• Device Catalogue Number: 6506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/19/2019
• 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: Hospitalization; Required Intervention