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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE LASER THERAPY PRODUCT Back to Search Results
Model Number PED-400-25
Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/14/2020
Event Type  Injury  
Manufacturer Narrative
The devices involved in the event has not been returned; therefore the event cause could not be determined. Correspondence has been sent out for return of the device. Once the device has been received and investigation completed. A supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the medtronic flow diverter middle and proximal section had difficulty opening and the distal pushwire separated from the position behind the recovery pad in the medtronic microcatheter. Prior to the event, the physician was in the process of releasing the medtronic flow diverter to the middle section of the medtronic microcatheter and then the reported event occurred. Resistance was felt in the distal part of the microcatheter during release of the flow diverter. After the distal pushwire broke, there was no more resistance felt. The pushwire was repeatedly manipulated to try to open the middle and proximal section of the flow diverter, but the proximal side could not be opened. Finally, the endoscope biopsy forceps were used to clamp the flow diverter to the recovery pad. Then the flow diverter was then push and pulled in order to release the flow diverter and the proximal end of the flow diverter was finally opened. The synchro guidewire could not reach the distal part through the medtronic flow diverter to retrieve the broken distal pushwire. The physician decided to leave the broken distal pushwire inside the patient and the surgery was completed. The tip of the medtronic microcatheter was observed to be accordioned after it was removed from the patient. The patient was awake after the surgery with stable signs. The patient had grade 4 upper muscle strength on the affected side and was in good condition to be released already.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceLASER THERAPY PRODUCT
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key9661333
MDR Text Key188889340
Report Number2029214-2020-00095
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-25
Device Catalogue NumberPED-400-25
Device Lot NumberA920066
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2019
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: 02/03/2020 Patient Sequence Number: 1
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