MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 3.5 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003N3EZ35200
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Subarachnoid (1893)
Date of Event	11/02/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
This is 1 out of 4 reports.The subject device is implanted.
Event or Problem Description
The patient had an un-ruptured, wide-neck, basilar tip aneurysm, and the physician wanted to place two aneurysm bridging stents in a y-stenting configuration in order to perform coiling embolization.It was reported that when the physician attempted to track a microcatheter through the lumen of the implanted stent (subject device), the stent marker bands moved distally.In spite of the stent movement, the patient remained in stable condition.The physician attempted to advance a competitor microcatheter over the guidewire through the lumen of the stent encountering resistance.The physician could not confirm if the competitor microcatheter had advanced through the lumen of the implanted stent; therefore, a dyna ct was performed to confirm position of the competitor microcatheter.The physician was unsuccessful in confirming position of the competitor microcatheter; therefore, removed the microcatheter and proceeded to advance a competitor balloon catheter over the guidewire.It was reported that during the process of advancement of the balloon and guidewire, the patient became very hypertensive.Contrast was injected revealing an extravasation coming from the basilar tip aneurysm area.The physician reversed the antiplatelet medication and coiled the aneurysm.In spite of the coil embolization, the extravasation continued.The physician ordered an external ventricular drain and the patient was transferred for a ct scan.It was later reported that the patient died.The physician¿s opinion of the patient¿s outcome of death in relationship to the devices was unknown.No further information is available.
Additional 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.Based on the information currently available patient¿s anatomy was noted to be very tortuous/tenuous and the customer used another device another which caused the stent migration.Therefore, operational context was assigned to the reported issue of stent migration.The reported patient complications 'patient hemorrhage', and 'patient death' are known risks associated with such procedures and noted as such in the directions for use (dfu).Therefore a root cause of anticipated patient complications has also been assigned to the event.
Event or Problem Description
The patient had an un-ruptured, wide-neck, basilar tip aneurysm, and the physician wanted to place two aneurysm bridging stents in a y-stenting configuration in order to perform coiling embolization.It was reported that when the physician attempted to track a microcatheter through the lumen of the implanted stent (subject device), the stent marker bands moved distally.In spite of the stent movement, the patient remained in stable condition.The physician attempted to advance a competitor microcatheter over the guidewire through the lumen of the stent encountering resistance.The physician could not confirm if the competitor microcatheter had advanced through the lumen of the implanted stent; therefore, a dyna ct was performed to confirm position of the competitor microcatheter.The physician was unsuccessful in confirming position of the competitor microcatheter; therefore, removed the microcatheter and proceeded to advance a competitor balloon catheter over the guidewire.It was reported that during the process of advancement of the balloon and guidewire, the patient became very hypertensive.Contrast was injected revealing an extravasation coming from the basilar tip aneurysm area.The physician reversed the antiplatelet medication and coiled the aneurysm.In spite of the coil embolization, the extravasation continued.The physician ordered an external ventricular drain and the patient was transferred for a ct scan.It was later reported that the patient died.The physician¿s opinion of the patient¿s outcome of death in relationship to the devices was unknown.No further information is available.

• Brand Name: NEUROFORM 3 EZ 3.5 X 20MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6135930
• Report Number: 3008881809-2016-00281
• Device Sequence Number: 16296734
• Product Code: NJE
• UDI-Device Identifier: 04546540697806
• UDI-Public: (01)04546540697806(17)180131(10)18246874
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: H020002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: M003N3EZ35200
• Device Lot Number: 18246874
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2016
• Supplement Report FDA Received Date: 02/14/2017
• 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: XT-27 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Death; Other; Required Intervention