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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY RX STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY RX STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number M00570480
Device Problems Difficult to Remove (1528); Material Integrity Problem (2978); Migration (4003)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 01/04/2021
Event Type  Injury  
Manufacturer Narrative
Exact implant date was unknown; however, it was reported that the stent was implanted in (b)(6) 2020.(b)(4).It is unknown if the device will 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) 2021 that a wallflex biliary fully covered rmv stent was implanted in the common bile duct to treat a suspected malignancy during a stent placement procedure performed in october.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, on (b)(6) 2021, during a scheduled endoscopic retrograde cholangiopancreatography (ercp) with stent removal procedure, the patient presented with pain and discomfort.It was noted that the stent appeared to be uncovered.The stent was attempted to be removed with a retrieval forceps but was unsuccessful.In the physician's assessment the pain and discomfort were reported to be slightly attributed to the stent and no interventions were reported.The patient's condition was reported to be fine.On an unknown date, the patient was brought back in for brushing to determine if the stricture was malignant.During the procedure, it was noted that the stent had migrated and the stent was successfully removed from the patient.Reportedly, the stent was visually inspected and it was confirmed that the stent cover was present but much of the silicon cover had eroded.
 
Manufacturer Narrative
Blocks b5, d6b, and h10 have been updated with additional information received on january 26, 2021.Block d6: exact implant date was unknown; however, it was reported that the stent was implanted in (b)(6) 2020.Block h6: medical device problem code a010402 captures the reportable event of stent migration.Medical device problem code a150207 captures the reportable event of stent difficult to remove.Medical device problem code a04 captures the reportable event of stent cover had eroded.Block h10: the complainant indicated that the device was 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) 2021 that a wallflex biliary fully covered rmv stent was implanted in the common bile duct to treat a suspected malignancy during a stent placement procedure performed in october.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, on (b)(6) 2021, during a scheduled endoscopic retrograde cholangiopancreatography (ercp) with stent removal procedure, the patient presented with pain and discomfort.It was noted that the stent appeared to be uncovered.The stent was attempted to be removed with a retrieval forceps but was unsuccessful.In the physician's assessment the pain and discomfort were reported to be slightly attributed to the stent and no interventions were reported.The patient's condition was reported to be fine.On an unknown date, the patient was brought back in for brushing to determine if the stricture was malignant.During the procedure, it was noted that the stent had migrated and the stent was successfully removed from the patient.Reportedly, the stent was visually inspected and it was confirmed that the stent cover was present but much of the silicon cover had eroded.Additional information received on january 26, 2021.It was reported that on (b)(6) 2021, the stent was successfully removed from the patient with a grasping forceps.
 
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Brand Name
WALLFLEX BILIARY RX STENT SYSTEM
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11228689
MDR Text Key241236201
Report Number3005099803-2021-00173
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/17/2022
Device Model NumberM00570480
Device Catalogue Number7048
Device Lot Number0025869076
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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