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

Model Number UNK60

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Infarction, Cerebral (1771)

Event Date 07/24/2014

Event Type  Injury  

Event Description

Same case as mdr 2134265-2014-04974.It was reported that cerebral infarct occurred.The target lesion was located in the right and left carotid arteries.The right internal carotid artery was noted to be 100% stenosed.The stenosis of the left internal carotid was unknown.It took the physician 50 minutes to place a filterwire ez 190cm and a wallstent.After deploying the filterwire and stent, the patient was unable to move his right leg.Computed tomography (ct) images revealed no infarct.The physician then took a radiographic image and it was noted that the previously implanted stent had retracted to the lower section of the stenosis.Another wallstent was implanted.The procedure was completed.After the procedure, the patient continued to be unable to move his leg and accepted thrombolytic therapy.A second ct scan revealed a cerebral infarct.The cause is unknown at this time.

Manufacturer Narrative

Age at time of event: over 70.Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, 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: 4016661
• MDR Text Key: 4845471
• Report Number: 2134265-2014-04976
• 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
• Type of Report: Initial
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• 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
• Date Manufacturer Received: 07/25/2014
• 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