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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT, COLONIC, METALIC, EXPANDABLE Back to Search Results
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.
 
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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 Key8213448
MDR Text Key131954092
Report Number3005099803-2018-62368
Device Sequence Number1
Product Code MQR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061877
Number of Events Reported1
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 Received01/03/2019
Supplement Dates Manufacturer Received01/11/2019
Supplement Dates FDA Received02/06/2019
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 Number1
Patient Outcome(s) Death; Required Intervention;
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