MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF F/G WINGSPAN STENT SYSTEM 3.0 X 9MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0300090

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

Patient Problems Thrombosis (2100); Transient Ischemic Attack (2109)

Event Date 05/23/2015

Event Type  Injury  

Manufacturer Narrative

Subject device remains implanted.

Event Description

It was reported that a patient was treated successfully for a minor stroke at the left middle cerebral artery (mca) with 99.0% stenosis with a percutaneous transluminal angioplasty (pta) balloon and stent system (subject device).Five months post-treatment, the patient experienced a transient ischemic attack (tia) due to in-stent (subject device) thrombosis.Seven months post-procedure, the patient underwent a bypass surgery in order to treat the tia and the patient recovered.

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However, vessel thrombosis and ischemia/infarct are known risks associated with endovascular procedures and 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

It was reported that a patient was treated successfully for a minor stroke at the left middle cerebral artery (mca) with 99.0% stenosis with a percutaneous transluminal angioplasty (pta) balloon and stent system (subject device).Five months post-treatment, the patient experienced a transient ischemic attack (tia) due to in-stent (subject device) thrombosis.Seven months post-procedure, the patient underwent a bypass surgery in order to treat the tia and the patient recovered.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3.0 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: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6171515
• MDR Text Key: 62312448
• Report Number: 3008881809-2016-00304
• 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: 03/02/2017

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: 02/28/2017
• Device Catalogue Number: M003WE0300090
• Device Lot Number: 16862222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2014
• 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: 69 YR