Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 5X20; INTRACRANIAL ANEURYSM FLOW DIVERTER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER NEUROVASCULAR CORK SURPASS 5X20; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003124FPP0
Device Problem Activation Failure (3270)
Patient Problems Aneurysm (1708); Stenosis (2263); Vascular Dissection (3160)
Event Date 04/11/2018
Event Type  Injury  
Manufacturer Narrative
This is 2 of the 2 reports for this event.The device remains in patient.
 
Event Description
It was reported that approximately 16 months after the procedure for the aneurysm at the right internal carotid, digital subtraction angiography (dsa) showed a non-optimal position of the fusiform aneurysm component of the internal carotid artery (ica) after dissection, provided by the flow diverter.Then approximately 2 months later, a percutaneous transluminal angioplasty (pta) of the flow diverter was performed several times to treat the dissection aneurysm.Good dilation result showed in the proximal flow diverter section, however no relevant enhancement in the distal end.Approximately 2 years after the initial procedure, dsa showed the depletion of the proximal lumen of the flow diverter increased again compared to right after the pta.And the flow diverter tapered lute-like towards the proximal end.The remaining partly incomplete wall adaption of the flow diverter with sufficient lumen and flow was not changed, not progressive.Intracranial perfusion also appeared unchanged and unaffected.In the physician¿s opinion, the event was related to the implanted flow diverter.
 
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the information currently available, the exact cause for the reported event of flow diverted failure to open cannot be determined.The reported event could not be confirmed; however, secondary stenosis is a known risk associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
 
Event Description
It was reported that approximately 16 months after the procedure for the aneurysm at the right internal carotid, digital subtraction angiography (dsa) showed a non-optimal position of the fusiform aneurysm component of the internal carotid artery (ica) after dissection, provided by the flow diverter.Then approximately 2 months later, a percutaneous transluminal angioplasty (pta) of the flow diverter was performed several times to treat the dissection aneurysm.Good dilation result showed in the proximal flow diverter section, however no relevant enhancement in the distal end.Approximately 2 years after the initial procedure, dsa showed the depletion of the proximal lumen of the flow diverter increased again compared to right after the pta.And the flow diverter tapered lute-like towards the proximal end.The remaining partly incomplete wall adaption of the flow diverter with sufficient lumen and flow was not changed, not progressive.Intracranial perfusion also appeared unchanged and unaffected.In the physician¿s opinion, the event was related to the implanted flow diverter.Additional information received from the site on 09-april-2019 clarified that the implanted flow diverter did not cause the patient's dissection.The site additionally reported that the proximally implanted flow diverter (lot 18849697) caused secondary stenosis in the patient.There were no adverse consequences or medical intervention performed in response to the stenosis.No further information is available for now.
 
Event Description
It was reported that approximately 16 months after the procedure for the aneurysm at the right internal carotid, digital subtraction angiography (dsa) showed a non-optimal position of the fusiform aneurysm component of the internal carotid artery (ica) after dissection, provided by the flow diverter.Then approximately 2 months later, a percutaneous transluminal angioplasty (pta) of the flow diverter was performed several times to treat the dissection aneurysm.Good dilation result showed in the proximal flow diverter section, however no relevant enhancement in the distal end.Approximately 2 years after the initial procedure, dsa showed the depletion of the proximal lumen of the flow diverter increased again compared to right after the pta.And the flow diverter tapered lute-like towards the proximal end.The remaining partly incomplete wall adaption of the flow diverter with sufficient lumen and flow was not changed, not progressive.Intracranial perfusion also appeared unchanged and unaffected.In the physician¿s opinion, the event was related to the implanted flow diverter.Additional information received from the site on 09-april-2019 clarified that the implanted flow diverter did not cause the patient's dissection.The site additionally reported that the proximally implanted flow diverter (lot 18849697) caused secondary stenosis in the patient.There were no adverse consequences or medical intervention performed in response to the stenosis.No further information is available for now.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8419017
MDR Text Key138759006
Report Number3008881809-2019-00071
Device Sequence Number0
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 04/22/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM003124FPP0
Device Lot Number18849697
Was Device Available for Evaluation? No
Date Manufacturer Received04/18/2019
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 Age48 YR
Patient Weight104
-
-