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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT®; STENT, CAROTID
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BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT®; STENT, CAROTID Back to Search Results
Model Number M001719010
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/01/2015
Event Type  Injury  
Event Description
It was reported that a shaft break occurred.The target lesion was located in the carotid artery.An 8x21, 5f, 135cm carotid wallstent® was advanced however, the shaft of the catheter was broken and the stent was dislodged from the delivery system.The catheter was removed and the undeployed stent remained inside the patient.Snaring was not performed as the clear protective sheath was still covering the stent.A non bsc stent was then deployed to trap the detached stent against the vessel wall.No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
(b)(4).Age at time of event: 18 years or older.(b)(4).
 
Manufacturer Narrative
(b)(4).Device evaluated by mfr: the proximal section of a carotid monorail stent delivery system was received for analysis.A break in the outer sheath was identified 168mm distal to the middle outer.The distal section of the break was retained inside the patient and was not received for analysis.Additionally it was noted that the outer sheath was severely kinked and stretched in the region of the break site and several other kinks were found along the length of the device.This type of damage is consistent with the application of excessive force to the delivery system.No other issues were identified during the product analysis.The damage identified during the product analysis is consistent with the application of excessive force.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that a shaft break occurred.The target lesion was located in the carotid artery.An 8x21, 5f, 135cm carotid wallstent® was advanced however, the shaft of the catheter was broken and the stent was dislodged from the delivery system.The catheter was removed and the undeployed stent remained inside the patient.Snaring was not performed as the clear protective sheath was still covering the stent.A non bsc stent was then deployed to trap the detached stent against the vessel wall.No patient complications were reported and the patient's status was fine.
 
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Brand Name
CAROTID WALLSTENT®
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4949565
MDR Text Key6040365
Report Number2134265-2015-04826
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/26/2018
Device Model NumberM001719010
Device Catalogue Number71-901
Device Lot Number17733381
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received09/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2015
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) Required Intervention;
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