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 Problems Stroke/CVA (1770); Transient Ischemic Attack (2109)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Event date: the exact date of the adverse event is unknown.All patients were treated between july 2007 and april 2013.This report is 2 out of 2 reports for this article.The subject device remains implanted.

Event Description

The literature article reported that 196 consecutive patients with severe middle cerebral artery (mca) atherosclerotic stenosis (=70 %) were treated with the subject stent were retrospectively studied.Within 30 days, 14 patients experienced stroke/transient ischemic attack (tia).It was not possible to ascertain specific device with patient information.No further information is available.

Manufacturer Narrative

The device history record review was unable to be performed as the lot number of the device was not reported.The subject device is not available; therefore analysis cannot be performed.From the information available, there is no indication that the reported event is related to product specifications nonconformance or misuse.There is also no indication that the subject device malfunctioned.However, stroke and transient ischemic attack (tia) are known risks associated with such procedures and noted as such in the directions for use (dfu).Therefore, a root cause of anticipated procedural complication has been assigned to the event.

Event Description

The literature article reported that 196 consecutive patients with severe middle cerebral artery (mca) atherosclerotic stenosis (=70 %) were treated with the subject stent were retrospectively studied.Within 30 days, 14 patients experienced stroke/transient ischemic attack (tia).It was not possible to ascertain specific device with patient information.No further information is 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: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5680799
• MDR Text Key: 45955723
• Report Number: 3008853977-2016-00191
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• 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
• Patient Outcome(s): Other