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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 Migration or Expulsion of Device (1395); Activation Failure (3270); Migration (4003)
Patient Problems Paralysis (1997); Paresis (1998); Thrombus (2101); Thromboembolism (2654)
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative
Subject device is not available.
 
Event Description
It was reported that during a flow diverter stenting of a sidewall paraopthalmic aneurysm procedure, the flow diverter (subject device) distal end was deployed and opened successfully. It was then resheathed to position more proximally as the end of the stent needed to be opened in a curve. A microcatheter was used to push the stent open. The stent was gently resheathed three to four times to allow the proximal end to open. The physician realized the stent was not going to open and decided to resheath the device so as to remove it from the patient anatomy. However, this was not possible as the stent had migrated distally, off the resheath pad. The distal access catheter was brought to try and capture the flow diverter, and a balloon was used to trap the flow diverter inside the distal access catheter so as to remove it from the patient anatomy. After the procedure, a thrombus was seen in the distal middle cerebral artery (mca) in occipital region and a distal thrombectomy was attempted. The patient suffered moderate paralysis of the right arm from this event. No further information is currently available.
 
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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 Key8881249
MDR Text Key153943145
Report Number3008881809-2019-00236
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
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,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/18/2020
Device Catalogue NumberUNK_NEU
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2019
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: 08/09/2019 Patient Sequence Number: 1
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