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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 40MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 40MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003113FPP0
Device Problems Activation Failure (3270); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  Injury  
Manufacturer Narrative
The device is not available to the manufacturer, as device is implanted in patient.
 
Event Description
It was reported that stent assisted coil embolization was performed for unruptured large aneurysm in ica (internal carotid artery). After the subject flow diverter stent deployment, it was noted that the distal of the stent was fully expanded but proximal of the stent was not fully expanded. Therefore, subject flow diverter stent was expanded with balloon catheter after deployment. As subject flow diverter stent was shortened and distal part was felled into the aneurysm. Therefore, another flow diverter stent was added. Due to this reported issue an unanticipated delay or prolongation to any medical procedures of two and half hours was noted. The procedure was completed successfully and the patient was stable. No other information is available.
 
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Brand NameSURPASS STREAMLINE 4.0MM X 40MM - CE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key12026209
MDR Text Key260564702
Report Number3008881809-2021-00259
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberM003113FPP0
Device Lot Number22510456
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2020
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: 06/18/2021 Patient Sequence Number: 1
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