MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE); INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number UNK_NEU

Device Problems Malposition of Device (2616); Activation Failure (3270)

Patient Problem Paresis (1998)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that during the procedure, the proximal portion of the flow diverter (subject device) did not fully expand open.The partially open flow diverter was left inside the patient anatomy and the procedure was completed with some coils to provide double anti-aggregation.The patient had left sided hemiparesis which resolved into a residual left arm deficit due to this event.No further information is available.

Event Description

It was reported that during the procedure, the proximal portion of the flow diverter (subject device) did not fully expand open.The partially open flow diverter was left inside the patient anatomy and the procedure was completed with some coils to provide double anti-aggregation.The patient had left sided hemiparesis which resolved into a residual left arm deficit due to this event.No further information is available.

Manufacturer Narrative

Product long description: unknown (surpass streamline).Catalog#: unknown.Lot/serial no.: unknown.The neurovascular stryker surpass evolve device is not currently not 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 (pma # p170024).

Event Description

It was reported that during the procedure, the proximal portion of the flow diverter (subject device) did not fully expand open.The partially open flow diverter was left inside the patient anatomy and the procedure was completed with some coils to provide double anti-aggregation.The patient had left sided hemiparesis which resolved into a residual left arm deficit due to this event.No further information is available.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Based on investigation results, the device was not returned as it was implanted.It cannot be determined from the available information if the patient neurological deficit is related to the device malfunction.An assignable cause of undeterminable will be assigned to the reported events.H3 other text : subject device is not available.

• Brand Name: UNKNOWN (SURPASS STREAMLINE)
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8846131
• MDR Text Key: 152792122
• Report Number: 3008881809-2019-00221
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2020
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCELSIOR XT-27 MICROCATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 80