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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD45017
Device Problem Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2020
Event Type  malfunction  
Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release. During visual inspection, the stent delivery wire (sdw) was returned within a dispenser hoop but the introducer sheath was not returned. The sdw was kinked at 40cm & 159cm from the proximal end and the returned catheter was noted to be flattened at 9. 5cm from the distal end. During functional test, a 0. 027¿ patency mandrel was advanced through the returned microcatheter and some resistance was experienced near the flattened section. When the patency mandrel was advanced to the distal tip of the microcatheter the subject stent was seen deployed from the microcatheter. There was some slight deformation noted to the both ends of the subject stent flow diverter. The reported event was confirmed. The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device. The reported event is covered in the device dfu. As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event. As per the complaint information, the tight curve at the middle part of the stent did not open despite many manipulations by the physician. The proximal part of the stent also opened but even after 3 times of resheathing the stent and reopening with different manipulations, the curve did not oppose to the wall of the vessel and the stent was removed. The patient's anatomy was of medium tortuosity and the appropriate size stent was selected for the treatment site. It is probable that the device was damaged during navigation through the patient's anatomy causing the reported failure of the stent to open and oppose the vessel wall. An assignable cause of procedural factors will be assigned to the reported and analysed events, as the issue is associated with a product that meets design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
 
Event Description
The stent (subject device) was returned for analysis and the device investigation revealed that the subject stent was seen to be deployed prematurely during use. No clinical consequences were reported to the patient due to this event.
 
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Brand NameSURPASS EVOLVE 4.5MM X 17MM - 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 Key11356824
MDR Text Key234219248
Report Number3008881809-2021-00091
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
P170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 02/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/26/2020
Device Catalogue NumberFD45017
Device Lot Number21707565
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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