MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 2.5 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003N3EZ25200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Infarction, Cerebral (1771); Neurological Deficit/Dysfunction (1982); Thrombosis (2100)
Date of Event	07/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
The patient presented with a right m1 occlusion.The patient underwent unsuccessful thrombectomy; therefore, the physician deployed a stent (subject device) from the posterior m2 division down to the m1 segment.It was reported that angiography showed in-stent thrombosis and 2 mg of integrilin were then administered to treat the stent thrombosis.Follow-up angiography showed that the anterior m2 branch remained occluded.After an unsuccessful attempt to access the occlusion to deploy another stent, the physician administered an additional 5 mg of integrilin to the right m1.Follow-up angiography demonstrated recanalization of the stented right m1 and posterior m2 division with minimal flow through the anterior m2 branch.A ct scan performed the following day showed extensive infarction of the entire right mca territory and mild increase in mass effect.The swelling continued to increase over time, and overall, the mass effect increased from 4 to 8 mm two days post procedure.This was associated clinically with increased somnolence and difficulties moving extremities.The physician reported that the in-stent thrombosis was related to the procedure and the patient's clinical situation, not the specific stent utilized.The patient's current status is a completed right mca whole territory infarct with expected swelling and mass effect.The patient is intubated and the family has made him comfort measures only.This is statistically the same outcome that would have occurred had no procedure been done.
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.However, vessel thrombosis, stroke and neurological/intracranial sequelae are known risks associated with endovascular procedure 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 or Problem Description
The patient presented with a right m1 occlusion.The patient underwent unsuccessful thrombectomy; therefore, the physician deployed a stent (subject device) from the posterior m2 division down to the m1 segment.It was reported that angiography showed in-stent thrombosis and 2 mg of integrilin were then administered to treat the stent thrombosis.Follow-up angiography showed that the anterior m2 branch remained occluded.After an unsuccessful attempt to access the occlusion to deploy another stent, the physician administered an additional 5 mg of integrilin to the right m1.Follow-up angiography demonstrated recanalization of the stented right m1 and posterior m2 division with minimal flow through the anterior m2 branch.A ct scan performed the following day showed extensive infarction of the entire right mca territory and mild increase in mass effect.The swelling continued to increase over time, and overall, the mass effect increased from 4 to 8 mm two days post procedure.This was associated clinically with increased somnolence and difficulties moving extremities.The physician reported that the in-stent thrombosis was related to the procedure and the patient's clinical situation, not the specific stent utilized.The patient's current status is a completed right mca whole territory infarct with expected swelling and mass effect.The patient is intubated and the family has made him comfort measures only.This is statistically the same outcome that would have occurred had no procedure been done.

• Brand Name: NEUROFORM 3 EZ 2.5 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: 5894263
• Report Number: 3008881809-2016-00131
• Device Sequence Number: 10922281
• Product Code: NJE
• UDI-Device Identifier: 04546540697745
• UDI-Public: (01)04546540697745(17)190131(10)18903596
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/01/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: M003N3EZ25200
• Device Lot Number: 18903596
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2016
• Supplement Report FDA Received Date: 11/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 57 YR