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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 H7493915010310
Device Problems Fracture (1260); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/17/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that catheter removal difficulties were encountered.The 90% stenosed target lesion was located in the severely tortuous and calcified internal carotid artery.After positioning a filter wire in the distal lesion, pre-percutaneous transluminal angioplasty was performed.A 10.0-31 carotid wallstent¿ was advanced to treat the lesion.However, during deployment when the stent had several centimeters more to be deployed completely, slight resistance was met.When the physician attempted to retract the stent into the sheath, the stent could not be retracted due to strong resistance.The device was then attempted to be retracted including the stent into the non-bsc guiding catheter but when the stent was pulled, the stent would not move and only the proximal delivery wire was pulled.The physician tried to push in the pulled delivery wire, then the outer sheath was moved and the stent was retracted.After that, the stent delivery system (sds) was advanced through the lesion together with the filter wire, and was then retracted into the guide catheter.Although the guide catheter got disengaged from the carotid artery, the sds crossed the lesion successfully and it was retracted into the guide catheter in the aorta.The procedure was then aborted.No patient complications were reported and the patient's status was good.
 
Manufacturer Narrative
Device evaluated by mfr: an examination of the returned device found a break in the shaft.The break was located at the guidewire monorail exit on the distal outer.An examination of the break site found that the outer was stretched at the site of the break.This type of damage is consistent with excessive force being applied to the delivery system during device use.The distal end of the device including the stent was not returned for analysis.No other issues were identified during the product analysis.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 catheter removal difficulties were encountered.The 90% stenosed target lesion was located in the severely tortuous and calcified internal carotid artery.After positioning a filter wire in the distal lesion, pre-percutaneous transluminal angioplasty was performed.A 10.0-31 carotid wallstent¿ was advanced to treat the lesion.However, during deployment when the stent had several centimeters more to be deployed completely, slight resistance was met.When the physician attempted to retract the stent into the sheath, the stent could not be retracted due to strong resistance.The device was then attempted to be retracted including the stent into the non-bsc guiding catheter but when the stent was pulled, the stent would not move and only the proximal delivery wire was pulled.The physician tried to push in the pulled delivery wire, then the outer sheath was moved and the stent was retracted.After that, the stent delivery system (sds) was advanced through the lesion together with the filter wire, and was then retracted into the guide catheter.Although the guide catheter got disengaged from the carotid artery, the sds crossed the lesion successfully and it was retracted into the guide catheter in the aorta.The procedure was then aborted.No patient complications were reported and the patient's status was good.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that the shaft broke while the device was still inside the patient and the device was not intact when removed from the patient.
 
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Brand Name
CAROTID WALLSTENT¿
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6185221
MDR Text Key62708739
Report Number2134265-2016-11808
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
PMA/PMN Number
P050019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/02/2019
Device Model NumberH7493915010310
Device Catalogue Number39150-1031
Device Lot Number0019212527
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE WIRE: FILTER WIRE; GUIDING CATHETER: CELLO 8FR
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