MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF UNKNOWN_NEUROVASCULAR_PRODUCT; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number UNK_NEU

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

Patient Problem Transient Ischemic Attack (2109)

Event Date 10/31/2011

Event Type  Injury  

Event Description

It was reported in a literature article that the patient suffered transient blindness and a transient ischemic attack (tia) during advancement of the stent delivery system.The procedure was stopped due to the tia.No other information is available.

Manufacturer Narrative

The cases in the literature article performed between february 2006 and october 2011; the exact date of the event being reported in unknown.The subject device was not returned for analysis; therefore, a visual inspection as well as a functional evaluation could not be performed.From the information available, there is no indication that the reported event is related to product specifications nonconformance or misuse.However, transient ischemic attack and neurological symptoms are known risks associated with endovascular procedures and are noted as such in the directions for use (dfu).Subject device is not available.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: kathleen shin ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 4604480
• MDR Text Key: 5698167
• Report Number: 3008853977-2015-00107
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2015
• 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