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U.S. Department of Health and Human Services

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

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STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number UNK_NEU
Device Problems Premature Activation (1484); Difficult or Delayed Activation (2577); Activation Failure (3270); Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/07/2019
Event Type  Injury  
Manufacturer Narrative
Subject device is not available.
 
Event Description
It was reported that during the procedure, the subject flow diverter was advanced through the micro catheter to the target vessel. The flow diverter was deployed in the first portion of the patient vessel and at a certain point near the carotid ophthalmic curve, it was unable to open. The physician performed a push and pull maneuver and re-sheathed the device three times. After the last maneuver, the physician noticed that the stent was not held anymore by the resheathing pad. Therefore the physician decided to complete deployment by pulling back the micro catheter and the stent opened well proximally but in the curve it was not well apposed so the physician used a balloon in order to post dilate. After dilation the stent was shortened more distally than proximally, leaving a portion of the aneurysm neck uncovered. So the physician decided to deploy a second device in order to better cover the aneurysm neck and continued the procedure without clinical consequences to the patient.
 
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Brand NameUNKNOWN (SURPASS STREAMLINE)
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key9200020
MDR Text Key162854640
Report Number3008881809-2019-00313
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/05/2020
Device Catalogue NumberUNK_NEU
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/16/2019 Patient Sequence Number: 1
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