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 UNKNOWN (SURPASS STREAMLINE); 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 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.
 
Manufacturer Narrative
The neurovascular stryker surpass evolve device is not currently not approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (pma # p170024).See section 4.11.3 guidance for industry and food and drug administration staff, november 8, 2016.
 
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.
 
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 re-sheathed 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 re-sheathed three to four times to allow the proximal end to open.The physician realized the stent was not going to open and decided to re-sheath the device so as to remove it from the patient anatomy.However, this was not possible as the stent had migrated distally, off the re-sheath 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.
 
Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the stent delivery wire was returned within the micro catheter.The stent was returned in its deployed state with blood / embolus within and was noted not to be fully opened and deformed.The stent delivery wire was kinked towards the distal end.The introducer sheath was not returned.No other anomalies were noted.A functional test was not performed as the stent had been deployed and the stent delivery wire was removed from the micro catheter without difficulty.The device was returned and the stent was noted to be deformed on the distal end and it was not opened fully, confirming the event.The thrombus which was reported to have been removed was noted within the returned stent.It is probable that the stent may have been damaged due to the resistance experienced during navigation, causing failure to open the stent.It is probable that the stent was deployed too far distally to allow it to be re-captured and migration from the re-sheath pad.The data reasonably suggest the clinical event is anticipated in nature, a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.Based on additional information, device analysis and medical review assessment, a probable cause of procedural factors will be assigned to the reported events of stent inability to open and stent migration and, anticipated procedural factors will be assigned to the reported events of patient thromboembolism and neurological deficit.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN (SURPASS STREAMLINE)
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
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
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 Health Professional
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
Date Manufacturer Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CATALYST 5 DISTAL ACCESS CATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER)
Patient Outcome(s) Other; Required Intervention;
Patient Age44 YR
-
-