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

Model Number H965SCH647070

Device Problem Occlusion Within Device (1423)

Patient Problems Intimal Dissection (1333); Stroke/CVA (1770); Thrombosis (2100)

Event Date 09/18/2016

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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).

Event Description

It was reported that vessel dissection and stent thrombosis occurred.In (b)(6) 2016, a 8.0-21 carotid wallstent was successfully deployed at the carotid artery.Two days later, the patient was admitted to the hospital due to stroke.Arteriography was performed and an intra-stent thrombus was noted and was diagnosed with carotid dissection.Another 8.0-21 carotid wallstent was then implanted to the carotid artery and the blood flow was re-established.However, the dissection remained and no other interventions were done.No further patient complications were reported and the patient's status was stable.

• Brand Name: CAROTID WALLSTENT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6034310
• MDR Text Key: 57642900
• Report Number: 2134265-2016-09161
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H965SCH647070
• Device Catalogue Number: SCH-64707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• 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
• Treatment: STENT: 8.0-21 CAROTID WALLSTENT¿
• Patient Outcome(s): Hospitalization; Required Intervention