MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT, COLONIC, METALIC, EXPANDABLE

Device Problem Activation Failure (3270)

Patient Problems Death (1802); Perforation (2001)

Event Date 12/01/2018

Event Type  Death  

Manufacturer Narrative

Date of event was approximated to be (b)(6) 2018 as no specific event date was reported.The complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex colonic stent has been implanted to treat an intrinsic tumor in the sigmoid colon during a colonic stent placement procedure performed on an unknown date.Reportedly, the patient's stricture was really tight.According to the complainant, during the procedure, the stent would not open due to the tight stricture.Reportedly, a balloon catheter was used to dilate and a perforation occurred.The patient eventually passed away.Despite numerous attempts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Date of event was approximated to be (b)(6) 2018 as no specific event date was reported.The complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.(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 on (b)(6) 2018 that a wallflex colonic stent has been implanted to treat an intrinsic tumor in the sigmoid colon during a colonic stent placement procedure performed on an unknown date.Reportedly, the patient's stricture was really tight.According to the complainant, during the procedure, the stent would not open due to the tight stricture.Reportedly, a balloon catheter was used to dilate and a perforation occurred.The patient eventually passed away.Additional information received on january 11, 2019.According to the complainant, the clinical cause of the patient's death was bowel perforation.Reportedly, the patient's tissue was friable.The indication for the wallflex colonic stent was a malignancy.During the procedure, the stent was fully deployed and was dilated.

• Brand Name: WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8213448
• MDR Text Key: 131954092
• Report Number: 3005099803-2018-62368
• Device Sequence Number: 1
• Product Code: MQR
• 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,Followup
• Report Date: 02/06/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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