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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR2; CATHETER, THROMBUS RETRIEVER

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MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR2; CATHETER, THROMBUS RETRIEVER Back to Search Results
Model Number SFR2-6-30
Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2022
Event Type  malfunction  
Event Description
Medtronic received a report that when the solitaire was loaded through the microcatheter, the distal segment of the solitaire was unable to open and they needed to give it more pressure, though the device still failed to open.When pressure was applied, it was noted that the pushed wire was damaged because of the proximal pressure applied.The stent was not positioned in a bend.A c arm was used during the procedure.The stent was deployed a bit distal to the clot location.The device was prepared as indicated in the ifu.There were no patient symptoms or complications associated with the event.The patient was being treated for an ischemic stroke.The patient's mrs baseline was 3 and the mrs procedure score was noted as thrombectomy.The patient's nihss score baseline was 15 and their post-procedure score was 19.The tici score baseline 2 and tici post-procedure was 3.An iv tpa was not contraindicated.There were 2 passes made with the device.The patient had moderate vessel tortuosity.The stroke onset to reperfusion time was 8.Ancillary devices include: a shuttle sheath, a dac 5f guide catheter, and a rebar microcatheter.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received indicating there was minimal damage/kink to the catheter.The physician determined the event might have been due to hard clot.
 
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.
 
Manufacturer Narrative
Product analysis: as found condition (condition of returned device): the solitaire fr stent was returned for analysis within a shipping box; within a sealed biohazard bag; within an opened solitaire fr stent outer carton; within an opened solitaire fr stent inner pouch and within a dispenser track.The rebar catheter used in the event was not returned.Visual inspection/damage location details: the model and lot numbers for the rebar catheter were not provided; therefore, compatibility could not be assessed.The solitaire fr stent device was returned within its introducer sheath with finger markers extending from distal tip of introducer sheath.The finger markers were examined and appeared to be entangled.The solitaire fr stent device was pushed out from within the introducer sheath without issue and finger markers became untangled.The solitaire ab pushwire was found to be kinked at ~182.3cm from proximal end.No bends or kinks were found with the marker coil.Visual inspection of the detachment zone revealed no electrical etching.The detachment zone was found to be visually acceptable.The stent was found to be still attached to the pushwire.The stent non-working (tear drop) and working length struts were in good condition.The finger markers were found to be in good condition.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿failure to open¿ was unable to be confirmed and root cause could not be determined.Possible causes of ¿failure to open¿ are damaged stent and finger entanglement.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.
 
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Brand Name
SOLITAIRE FR2
Type of Device
CATHETER, 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 Key13390434
MDR Text Key294484316
Report Number2029214-2022-00119
Device Sequence Number1
Product Code NRY
UDI-Device Identifier00847536020733
UDI-Public00847536020733
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/29/2022
Device Model NumberSFR2-6-30
Device Catalogue NumberSFR2-6-30
Device Lot NumberA970251
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age35 YR
Patient SexFemale
Patient Weight70 KG
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