• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR4 CATHETER, THROMBUS RETRIEVER

  • 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
 

MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR4 CATHETER, THROMBUS RETRIEVER Back to Search Results
Model Number SFR4-4-40-10
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/19/2022
Event Type  Injury  
Event Description
Medtronic received information that a solitaire sfr4 stent had resistance in the distal section of the catheter ad disconnected. There was considerable resistance from the first time of thrombus collection. The stent had resistance, but the entire blood vessel was calcified and the ic's arteriosclerosis was strong. Somewhat the resistance was convincing. Resistance was felt in the second pass, but it seemed to be slightly open. When the 3rd pass was performed, the stent was cut off, leaving the stent in the ic to m1, resulting in m1 blockage. In the 3rd pass, the react was removed and was pulled only with the stent. The microcatheter was not covered by the stent's proxy marker when the stent was being pulled. The resistance was at the time of collection. The blood vessel had strong tortuosity. There vascular stenosis proximal to the thrombus formation site. 3 passes were preformed with the same stent. The proximal marker of the stent was not located within the microcatheter when the stent was collected. The stent is within the patient's body in the ic top to m1. No surgical or medical intervention is required. The surgeon did not attempt to dislodge the stent. The patient was being treated for an ischemic cerebral infarction in the m2 location.  nihss (pre-operative) 21. Nihss (postoperative) 21. The patient had health damage.   ancillary devices: optimo 9f guiding catheter, track21 microcatheter.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSOLITAIRE FR4
Type of DeviceCATHETER, THROMBUS RETRIEVER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key15238186
MDR Text Key298025911
Report Number2029214-2022-01387
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K113455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSFR4-4-40-10
Device Catalogue NumberSFR4-4-40-10
Device Lot NumberB187771
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-