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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 5X20; INTRACRANIAL ANEURYSM FLOW DIVERTER
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STRYKER NEUROVASCULAR CORK SURPASS 5X20; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003124FPP0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 06/13/2018
Event Type  Injury  
Manufacturer Narrative
This is 2 of the 2 reports.The device remains in patient.
 
Event Description
It was reported that approximately 7 months after the procedure for the aneurysm at the left internal carotid, intima hyperplasia was noticed within the flow diverter.It led to a considerable narrowing of the lumen and a reduction of the flow.Therefore, a dsa (digital subtraction angiography) "in stent flow diverter pta (transluminal angioplasty)" was carried out 3 days later.Then the event was resolved without sequelae and the patient was discharged from hospital 4 days after the surgery.In the physician¿s opinion, the event was unrelated to the procedure, the implanted flow diverter or the delivery system.No further information is available for now.
 
Manufacturer Narrative
Executive summary: updated (based on additional information received on 20-feb-2019 that the site updated the relationship from unrelated to related for the implanted flow diverter.).
 
Event Description
It was reported that approximately 7 months after the procedure for the aneurysm at the left internal carotid, intima hyperplasia was noticed within the flow diverter.It led to a considerable narrowing of the lumen and a reduction of the flow.Therefore, a dsa (digital subtraction angiography) "in stent flow diverter pta (transluminal angioplasty)" was carried out 3 days later.Then the event was resolved without sequelae and the patient was discharged from hospital 4 days after the surgery.In the physician¿s opinion, the event was unrelated to the procedure and the delivery system but related to the implanted flow diverter.
 
Manufacturer Narrative
A review of the device history record could not be performed because the lot number was not reported.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.The reported stenosis is a known risk associated with endovascular procedures and is listed as such in the device directions for use.Therefore, an assignable cause of known inherent risk of device has been assigned to the reported event.
 
Event Description
It was reported that approximately 7 months after the procedure for the aneurysm at the left internal carotid, intima hyperplasia was noticed within the flow diverter.It led to a considerable narrowing of the lumen and a reduction of the flow.Therefore, a dsa (digital subtraction angiography) "in stent flow diverter pta (transluminal angioplasty)" was carried out 3 days later.Then the event was resolved without sequelae and the patient was discharged from hospital 4 days after the surgery.In the physician¿s opinion, the event was unrelated to the procedure, the implanted flow diverter or the delivery system.No further information is available for now.
 
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Brand Name
SURPASS 5X20
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
MDR Report Key8158441
MDR Text Key130166241
Report Number3008881809-2018-00525
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
Type of Report Initial,Followup,Followup
Report Date 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberM003124FPP0
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SURPASS FLOW DIVERTER (STRYKER)
Patient Outcome(s) Other; Required Intervention;
Patient Age67 YR
Patient Weight90
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