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

Model Number M00565110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Unspecified Infection (1930); Pain (1994); Perforation (2001); No Code Available (3191)

Event Date 11/06/2017

Event Type  Death  

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 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
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7068720
• MDR Text Key: 93350920
• Report Number: 3005099803-2017-03583
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456582
• UDI-Public: 08714729456582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• 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): Death; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 71