MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID

Model Number 26606

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that removal difficulty occurred.The 80% stenosed target lesion was located in the moderately tortuous internal and common carotid arteries.A non-bsc balloon was used to predilate the lesion followed by placement of a 10 mm x 24 mm carotid wallstent stent.After the delivery of the device, the catheter was attempted to be retrieved but was stuck.A non-bsc retrieval device was advanced but got stuck.The physician tried to advance the retrieval catheter again but it still would not advance.The carotid wallstent and retrieval catheter were removed together with a snare.No patient complications were reported.

Manufacturer Narrative

E1.Initial reporter address 1:(b)(6).Device evaluated by mfr.: a carotid device was returned for analysis.A visual and tactile examination identified that the shaft of the device was detached 44mm proximal from the distal tip.The device was received with the stent deployed from the delivery system.

Event Description

It was reported that removal difficulty occurred.The 80% stenosed target lesion was located in the moderately tortuous internal and common carotid arteries.A non-bsc balloon was used to pre-dilate the lesion followed by placement of a 10 mm x 24 mm carotid wallstent stent.After the delivery of the device, the catheter was attempted to be retrieved but was stuck.A non-bsc retrieval device was advanced but got stuck.The physician tried to advance the retrieval catheter again but it still would not advance.The carotid wallstent and retrieval catheter were removed together with a snare.No patient complications were reported.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12675375
• MDR Text Key: 277731335
• Report Number: 2134265-2021-12808
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0027223808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER: SHIDEN 4MMX30MM; BALLOON CATHETER: SHIDEN 4MMX30MM; BALLOON GUIDE CATHETER: OPTIMO 9FR; BALLOON GUIDE CATHETER: OPTIMO 9FR; GUIDEWIRE: PERCUSURGE, CHIKAI 0.014IN; GUIDEWIRE: PERCUSURGE, CHIKAI 0.014IN; RETRIVAL DEVICE: SPIDER; RETRIVAL DEVICE: SPIDER; BALLOON CATHETER: SHIDEN 4MMX30MM; BALLOON GUIDE CATHETER: OPTIMO 9FR; GUIDEWIRE: PERCUSURGE, CHIKAI 0.014IN; RETRIVAL DEVICE: SPIDER
• Patient Outcome(s): Required Intervention
• Patient Sex: Male