Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID Back to Search Results
Model Number 26605
Device Problems Break (1069); Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2023
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left internal carotid artery (ica) c1 segment.The patient was in a lying position, and the bilateral groin areas were routinely sterilized with surgical drape and lidocaine was used for local anesthesia.The left femoral artery was punctured, and an 8f sheath was used and placed.Angiography revealed severe stenosis in the origin segment of the left ica.A p150 190cm guidewire was selected and crossed, a filter wire ez was used to cross the stenosis under the diagram to reach the distal end of the ica c1.A 4mmx30cm sterling balloon was dilated at 8 atmospheres to reach the stenosis along the guidewire and was accurately positioned, after the pressure was released, the balloon was withdrawn.It was found in angiography that the stenosis was less than before.A 10.0-31 carotid wallstent was selected to deploy at the lesion.However, it was found that the stent could not be pushed out of the delivery catheter, and the delivery catheter was fractured.The stent was simply pulled out and the procedure was completed with another of the same device.The filterwire was recaptured and there were no patient complications reported, and the patient was stable post-procedure.
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6) updated fields: g2 - mfr contact first name, mfr contact last name, mfr contact phone number, mfr contact email device evaluated by mfr.: carotid wallstent monorail 10.0-31 was received for analysis.A visual and tactile examination identified a complete detachment of the outer sheath of the device located approximately 80mm distal of the guidewire port.This type of damage is consistent with excessive force being applied to the device when attempting deployment.The device was returned with the stent in the correct position on the delivery system.The investigator was unable to deploy the stent due to a separation of the outer sheath of the device.This concludes the product analysis.
 
Event Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left internal carotid artery (ica) c1 segment.The patient was in a lying position, and the bilateral groin areas were routinely sterilized with surgical drape and lidocaine was used for local anesthesia.The left femoral artery was punctured, and an 8f sheath was used and placed.Angiography revealed severe stenosis in the origin segment of the left ica.A p150 190cm guidewire was selected and crossed, a filter wire ez was used to cross the stenosis under the diagram to reach the distal end of the ica c1.A 4mmx30cm sterling balloon was dilated at 8 atmospheres to reach the stenosis along the guidewire and was accurately positioned, after the pressure was released, the balloon was withdrawn.It was found in angiography that the stenosis was less than before.A 10.0-31 carotid wallstent was selected to deploy at the lesion.However, it was found that the stent could not be pushed out of the delivery catheter, and the delivery catheter was fractured.The stent was simply pulled out and the procedure was completed with another of the same device.The filterwire was recaptured and there were no patient complications reported, and the patient was stable post-procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17248782
MDR Text Key318570202
Report Number2124215-2023-32597
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0030044252
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2022
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
4MMX30CM STERLING BALLOON CATHETER; 4MMX30CM STERLING BALLOON CATHETER; 8F GUIDE CATHETER; 8F GUIDE CATHETER; P150 190CM GUIDEWIRE; P150 190CM GUIDEWIRE
Patient Age67 YR
Patient SexMale
Patient Weight79 KG
-
-