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

Model Number M00565100

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

Patient Problems Death (1802); Peritonitis (2252); Bowel Perforation (2668)

Event Date 09/17/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).The complainant indicated that the 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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a wallflex colonic stent was implanted to treat a 3cm malignant stricture in the sigmoid colon during a colonic stent implantation procedure performed on (b)(6) 2015.The patient had stage 4 bowel cancer, metastasis of the liver, and kidney disorder.Reportedly, the lesion was tortuous.According to the complainant, the stent implantation procedure was being performed as a bridge to surgery.On (b)(6) 2015, the physician reported that the stent implantation procedure was difficult and took 100 minutes to complete.The patient was discharged from the hospital on (b)(6) 2015 and was having regular meals.On (b)(6) 2015, the patient presented with abdominal pain and an elevated c-reactive protein (crp) level.A ct scan was performed revealing a perforation at the sigmoid colon and perforative peritonitis.In the physician's assessment, the perforation was caused by the distal end of the stent and the difficulty during implantation may have contributed to the perforation.Due to the patient's medical history, the patient did not wish to receive any treatment for the perforation.The physician reported that the patient died from perforative peritonitis.

• 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: 5169987
• MDR Text Key: 29003109
• Report Number: 3005099803-2015-03021
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• 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: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/07/2017
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 18172419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2015
• Initial Date FDA Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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
• Patient Age: 80 YR