MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Unspecified Infection (1930); Pain (1994); Perforation (2001); No Code Available (3191)
Date of Event	11/06/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4) is being used to capture the reported event of pneumoperitoneum.(b)(4) (infection) relates to the reported event of sepsis.The complainant indicated that the device has been disposed 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 (b)(6) 2017 that a wallflex colonic stent was implanted in the sigmoid and descending colon to treat a malignant (t4/n2) colonic obstruction during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was somewhat tortuous and was not dilated prior to stent placement.According to the complainant, on (b)(6) 2017, during the procedure, the physician was able to deploy the stent successfully.However, on the same day after the procedure, the patient was in pain.The physician performed an imaging procedure and the patient¿s proximal anatomy was noted to be perforated and there was free air in the patient's peritoneal space (pneumoperitoneum); the patient also presented with sepsis.The patient had to undergo colonic resection surgery to repair the perforation and was given antibiotics to treat the sepsis.The stent was excised during the surgery and the patient¿s anatomy was noted to be friable on the proximal side of the stricture.In the physician¿s assessment, the stent was related to the perforation, which caused the patient to develop sepsis.On (b)(6) 2017, the patient expired due to sepsis.

• Brand Name: WALLFLEX¿ COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7068720
• Report Number: 3005099803-2017-03583
• Device Sequence Number: 1744727
• Product Code: MQR
• UDI-Device Identifier: 08714729456582
• UDI-Public: 08714729456582
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2019
• Device Model Number: M00565110
• Device Catalogue Number: 6511
• Device Lot Number: 0020245364
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 11/29/2017
• 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: Death; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 71