MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT?; STENT, CAROTID

Model Number H7493915010240

Device Problems Bent (1059); Migration or Expulsion of Device (1395); Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 07/07/2014

Event Type  Injury  

Event Description

It was reported that stent thrombosis, stent migration and stent shortening occurred.In (b)(6) 2012, the 99% stenosed, 3.0mm in diameter target lesion being treated was located in the mildly calcified and moderately tortuous internal carotid artery.A 10.0x24 carotid wallstent¿ stent was deployed.Post procedure, angiography was performed and it was confirmed that the stent was deployed properly.In (b)(6) 2014, the patient was scheduled for carotid artery stenting (cas); however, it was noted that stenosis was progressing and there was thrombosis.Anticoagulant therapy was taken and the cas was postponed as the physician decided to take a wait and see approach.Follow-up angiography was performed.It was noted that the stent shortened about 20mm and the deployed stent had migrated to the common carotid artery and would not cover the lesion in the internal carotid artery.Computed tomography (ct) image showed that the shortened stent was deployed in the common carotid artery but not in the target lesion.It was noted that there was no sign of stent fracture.The procedure was completed with this device.No further patient complications were reported.

Manufacturer Narrative

Age at time of event: 18 years or older.  (b)(4).Device evaluated by mfr.:it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3956121
• MDR Text Key: 4563354
• Report Number: 2134265-2014-04485
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P050019
• 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
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493915010240
• Device Catalogue Number: 39150-1024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other