• 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 EXCELSIOR SL-10 PRE-SHAPED J 150CM CATHETER, PERCUTANEOUS

  • 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 EXCELSIOR SL-10 PRE-SHAPED J 150CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number M0031681920
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aneurysm (1708); Hemorrhage, Subarachnoid (1893); Rupture (2208)
Event Date 10/03/2017
Event Type  Injury  
Manufacturer Narrative
A review of the device history record could not be performed because the lot number was not reported. The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed. However, the reported aneurysm rupture and hemorrhage are known risks associated with endovascular procedures and are listed as such in the device directions for use. Therefore, an assignable cause of known inherent risk of procedure has been assigned to the reported aneurysm rupture and hemorrhage.
 
Event Description
During the stent assisted coil embolization procedure for the a-com unruptured aneurysm (dome 16mm/ neck 7mm), a (non stryker) microcatheter was advanced into the aneurysm and the other microcatheter (subject device) was advanced to a2. It was reported that when a stent was advanced in the subject microcatheter over the aneurysm neck, an increase in blood pressure was noticed and the contrast leaking from the aneurysm was confirmed through angiography. However; the physician could not identify the source of bleeding, he thought that the bleeding source was coming from the neck of the aneurysm. Then the stent was deployed a2 to a1 and the coil was implanted. External ventricular drainage was done and hemorrhage was confirmed hours later. The patient condition was severe. No further information is available now.
 
Manufacturer Narrative
The subject device is not available.
 
Event Description
During the stent assisted coil embolization procedure for the a-com unruptured aneurysm (dome 16 mm/ neck 7 mm), a (non stryker) microcatheter was advanced into the aneurysm and the other microcatheter (subject device) was advanced to a2. It was reported that when a stent was advanced in the subject microcatheter over the aneurysm neck, an increase in blood pressure was noticed and the contrast leaking from the aneurysm was confirmed through angiography. However; the physician could not identify the source of bleeding, he thought that the bleeding source was coming from the neck of the aneurysm. Then the stent was deployed a2 to a1 and the coil was implanted. External ventricular drainage was done and hemorrhage was confirmed hours later. The patient condition was severe. No further information is available now.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXCELSIOR SL-10 PRE-SHAPED J 150CM
Type of DeviceCATHETER, PERCUTANEOUS
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 Key6996648
MDR Text Key110075811
Report Number3008881809-2017-00462
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K042568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberM0031681920
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/02/2017 Patient Sequence Number: 1
Treatment
ECHELON 10 MICROCATHETER (MEDTRONIC); NEUROFORM ATLAS STENT (STRYKER)
-
-