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

Model Number UNK60

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 10/29/2013

Event Type  Injury  

Event Description

It was reported that stent thrombosis occurred.On (b)(6) 2013, carotid wallstent deployment was performed with a non-bsc proximal cerebral protection system.It was 55% stenosed lesion from right internal carotid artery to common carotid artery.After blocking the flow of blood with the non-bsc cerebral protection system, the stent was deployed without performing pre-dilatation.Post-dilatation was performed at the site with an unspecified balloon catheter where the stent was deployed and the procedure was completed successfully.The lesion resulted in 0% stenosis.Time of blood flow blockage by the cerebral protection system was not measured.Bayaspirin, clopidogrel and pletaal were administered as pretreatment and combination treatment.Also, filter wire ez was concomitantly used as the protection device during stent deployment, post-dilatation and aspiration of blood clot, since oxygen desaturation was confirmed regionally during procedure.There were no changes on preoperative and postoperative clinical course, and the health damage to the patient was not confirmed.On the 5th day after the procedure, in-stent thrombosis was confirmed by the echo in carotid.Echo revealed 1.7mm defect.On (b)(6) 2013, the defect was found to be bigger.It was confirmed that the stenosis rate in the carotid artery was 60% based on (b)(6).Emergency pta was performed.The patients status was stable.

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).

• Brand Name: CAROTID WALLSTENT MONORAIL
• 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: 4033783
• MDR Text Key: 17694713
• Report Number: 2134265-2014-05043
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2014
• 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
• Treatment: GUIDEWIRE: FILTERWIRE EZ
• Patient Outcome(s): Required Intervention