MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF F/G WINGSPAN STENT SYSTEM 2.5 X 9MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0250090

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

Patient Problems Transient Ischemic Attack (2109); Stenosis (2263)

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

This is 1 of 4 reports filed (1 stent & 3 balloons) for the reported event.Subject device is implanted.

Event Description

The patient was undergoing balloon angioplasty when vessel spasm occurred in the treated lesion; therefore, the physician deployed a stent (subject device) to keep the patency of the vessel.The procedure was completed without further patient complications.It was reported that approximately seven days post initial procedure, the patient developed transient ischemic attack symptoms.Unknown imaging test revealed in-stent re-stenosis.The patient was scheduled for in-stent balloon angioplasty to treat the in-stent restenosis two days post imaging finding.It was reported that during balloon angioplasty dilation of the stenosed stent, vessel spasm occurred.The physician switched to another balloon catheter and dilated but slight vessel spasm was observed.However, anterograde flow was maintained, so the procedure was finished.The patient was reported to be released with a modified ranking scale (mrs) of 1.No further information is available.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.However, restenosis and transient ischemic attack (tia) are known risks associated with endovascular procedures and are noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.

Event Description

The patient was undergoing balloon angioplasty when vessel spasm occurred in the treated lesion; therefore, the physician deployed a stent (subject device) to keep the patency of the vessel.The procedure was completed without further patient complications.It was reported that approximately seven days post initial procedure, the patient developed transient ischemic attack symptoms.Unknown imaging test revealed in-stent re-stenosis.The patient was scheduled for in-stent balloon angioplasty to treat the in-stent restenosis two days post imaging finding.It was reported that during balloon angioplasty dilation of the stenosed stent, vessel spasm occurred.The physician switched to another balloon catheter and dilated but slight vessel spasm was observed.However, anterograde flow was maintained, so the procedure was finished.The patient was reported to be released with a modified ranking scale (mrs) of 1.No further information is available.

• Brand Name: F/G WINGSPAN STENT SYSTEM 2.5 X 9MM
• 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: 5779086
• MDR Text Key: 49073058
• Report Number: 3008881809-2016-00071
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

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 Expiration Date: 03/31/2017
• Device Catalogue Number: M003WE0250090
• Device Lot Number: 16828525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2014
• 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; Required Intervention
• Patient Age: 63 YR