MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.0 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003WS0300150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hemorrhage, Cerebral (1889); Thrombosis (2100)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient.
Event or Problem Description
The patient underwent a neuro stenting (subject device) surgical procedure to place a stent in the lica (left internal carotid artery) and lmca (left middle cerebral artery).It was reported that post procedure, the patient suffered from a large left mca stroke.Further hospitalization of the patient was complicated by aspiration resulting in mdr (multidrug-resistant) pneumonia with acute hypoxic failure and ards (acute respiratory distress syndrome) requiring intubation.The patient also developed a lower gi (gastrointestinal) bleed.In addition, the lica/mca stented areas went on to occlude and a pontine intracerebral hemorrhage also occurred.It was reported that the patient passed away due to cardiopulmonary arrest approximately 17 days post the index procedure.The physician has stated that the stent(s) did not malfunction.No further information is available.
Additional Manufacturer Narrative
Manufacturing date ¿ added.Expiration date ¿ added.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.However, stroke, thromboembolic and hemorrhagic events 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 complications was assigned to this event.
Event or Problem Description
The patient underwent a neuro stenting (subject device) surgical procedure to place a stent in the lica (left internal carotid artery) and lmca (left middle cerebral artery).It was reported that post procedure, the patient suffered from a large left mca stroke.Further hospitalization of the patient was complicated by aspiration resulting in mdr (multidrug-resistant) pneumonia with acute hypoxic failure and ards (acute respiratory distress syndrome) requiring intubation.The patient also developed a lower gi (gastrointestinal) bleed.In addition, the lica/mca stented areas went on to occlude and a pontine intracerebral hemorrhage also occurred.It was reported that the patient passed away due to cardiopulmonary arrest approximately 17 days post the index procedure.The physician has stated that the stent(s) did not malfunction.No further information is available.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3.0 X 15MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6519945
• Report Number: 3008881809-2017-00126
• Device Sequence Number: 736618
• Product Code: NJE
• UDI-Device Identifier: 04546540722805
• UDI-Public: (01)04546540722805(17)190228(10)18906081
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: M003WS0300150
• Device Lot Number: 18906081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WINGSPAN STENT (STRYKER); WINGSPAN STENT (STRYKER)
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 109