MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number UNK_NEU

Device Problem Activation Failure (3270)

Patient Problems Infarction, Cerebral (1771); Death (1802); Thromboembolism (2654)

Event Date 02/12/2020

Event Type  Death  

Manufacturer Narrative

Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The device was intended to be used for treatment.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.As per the available information, after initial placement of the subject flow diverter, it was is verified under fluoroscopy that there was correct wall apposition.The patient¿s anatomy was averagely tortuous.As the device was not returned and it cannot be definitively determined what caused the stent not to open proximally, an assignable cause of undeterminable will be assigned to the reported stent failure to open.It cannot be definitively determined that the reported patient harm was related to the device malfunction, therefore an assignable cause of undeterminable will be assigned to the reported patient thromboembolic event, patient stroke, and patient death.The neurovascular stryker surpass evolve device is not currently approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (b)(4).Subject device remains implanted.

Event Description

It was reported that the patient underwent successful flow diverter stenting artery to treat an aneurysm in the right internal carotid.After initial placement of the subject flow diverter, it was verified under fluoroscopy that there was correct wall apposition.12 hours post-procedure, the patient presented neurological deterioration.Diagnostic images revealed hypoperfusion of the right cerebral hemisphere, due to multiple thrombus in the right supraclinoid internal carotid and in the proximal and distal ipsilateral middle cerebral artery.It was observed that the right anterior cerebral artery territory received collateral flow from the left internal carotid artery through the anterior communicating artery.Thrombectomy by aspiration was successfully performed and at fluoroscopy, the proximal section of flow diverter stent had a cone-shaped closed section.Tomographic control imaging revealed cerebral edema and midline deviation.Continuous comprehensive rehabilitation plan was in place.Patient died 7 days post-procedure.According to the physician, the adverse event of thrombus was related to the subject device ¿closed cone-shaped section¿ issue.It is unknown what the reason for the death was.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 9808594
• MDR Text Key: 182686913
• Report Number: 3008881809-2020-00060
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_NEU
• Device Lot Number: 21638967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death; Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 65