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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX LASER THERAPY PRODUCT Back to Search Results
Model Number PED-500-20
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline failed to open, and the marksman was accordioned. The patient was undergoing surgery for treatment of a left side, saccular, unruptured aneurysm with a max diameter of 8 mm and a 5 mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unknown. It was reported that during implantation, the pipeline tip was flattened after the stent opened at the m1 segment. The stent was still flattened after continued opening for 10 mm. Resheathing and redeployment was performed more than twice, but the pipeline still failed to open distally. It was noted the stent was not in a bend, less than 50% had been deployed, and no additional steps were done to open the device. The entire system was removed, and it was found the marksman microcatheter was accordioned in the distal segment. A new stent and microcatheter were used to complete the surgery. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Ancillary devices include a cook sheath.
 
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Brand NamePIPELINE FLEX
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 Key10541400
MDR Text Key207179173
Report Number2029214-2020-00933
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 12/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-20
Device Catalogue NumberPED-500-20
Device Lot NumberA900745
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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