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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE
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BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE Back to Search Results
Model Number M00565100
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2019
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address: (b)(6).(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 november 22, 2019 that a wallflex colonic stent was to be used to treat a malignant obstruction in the colon during a stenting procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, the guidewire was advanced through the stenosis.The physician was about to advance the stent to cross the stenosis with the help of the guidewire; however, the guidewire could only advance a small part of the guidewire lumen in the stent.The guidewire and the stent was removed together from the patient and it was noted that the metal stent was visibly kinked.Another wallflex colonic stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: problem code 2976 captures the reportable event of stent kinked.Block h10: a wallflex colonic stent and delivery system were received for analysis.The stent was received not deployed and was fully covered by the outer sheath.Visual examination of the returned device found that the stainless steel tube was kinked.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received; however, the stent was deployed manually by gripping the outer sheath and pulling the tip distally.The stent was measured to be within specifications.No other issues with the stent and delivery system were noted.Taking all available information into consideration, the investigation concluded that the reported event and the observed failure are likely due to anatomical and procedural factors such as lesion characteristics, handling of the device, the technique used by the user, and normal procedural difficulties encountered during the procedure, which limited the performance of the device.Therefore, the most probable root cause is adverse event related to the procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.
 
Event Description
It was reported to boston scientific corporation on november 22, 2019 that a wallflex colonic stent was to be used to treat a malignant obstruction in the colon during a stenting procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, the guidewire was advanced through the stenosis.The physician was about to advance the stent to cross the stenosis with the help of the guidewire; however, the guidewire could only advance a small part of the guidewire lumen in the stent.The guidewire and the stent was removed together from the patient and it was noted that the metal stent was visibly kinked.Another wallflex colonic stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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Brand Name
WALLFLEX COLONIC
Type of Device
STENT, COLONIC, METALIC, EXPANDABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9461500
MDR Text Key189775905
Report Number3005099803-2019-05974
Device Sequence Number1
Product Code MQR
UDI-Device Identifier08714729456575
UDI-Public08714729456575
Combination Product (y/n)N
PMA/PMN Number
K061877
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/03/2020
Device Model NumberM00565100
Device Catalogue Number6510
Device Lot Number0023030396
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2019
Date Manufacturer Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age78 YR
Patient Weight82
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