• 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); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/07/2022
Event Type  malfunction  
Event Description
Medtronic received information that a solitaire sfr4 stent pushwire broke. The stent unintentionally detached. The sfr4 tracked through system and deployed at m1ca. Traction applied and sfr4 pulled back to terminal internal carotid artery (ica) where it became stuck. Operator believed that the ica may have been heavily calcified - preventing recapture of the sfr4 via the phenom 21. Operator states applied considerable traction to the sfr4 and system yet it would not move. Operator states that usually resolution of this kind of complication can be found by recapturing the phenom 21 microcatheter with a long intermediate catheter. However, 115cm axs was not long enough to achieve this. Operator states that detachment of the sfr4 from the push wire was the best outcome in the situation. The pushwire separation occurred in the distal portion proximal to the stent. Unsure how much of the pushwire remains in the patient. Resistance occurred. All broken segments of the pushwire was removed from the patient. The stent remains in patient. The devices were prepared as indicated in the instructions for use (ifu). The patient was being treated for an ischemic stroke. She was being treated for a ica m1ca occlusion. No patient symptoms were reported. Operator states no iatrogenic event.   ancillary devices: axs cat 5 115cm intermediate catheter, phenom 21 160cm 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 Key15230148
MDR Text Key303741394
Report Number2029214-2022-01371
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
Reporter Country CodeUK
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 09/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSFR4-4-40-10
Device Catalogue NumberSFR4-4-40-10
Device Lot NumberB393173
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/31/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-