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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-10
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problems Fistula (1862); Foreign Body In Patient (2687)
Event Date 12/19/2019
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis, as the stent and the proximal segment of the delivery system was left in the patient, and the proximal segment was kept by the treating facility. Since the device was not returned, we are unable to perform root cause analysis. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the pipeline flex implant was successful. However, the distal end of pipeline delivery wire broke and was left in the vessel. The proximal end of wire created an arteriovenous fistula (avf) into what the doctor believed to be the inferior petrosal vein with visible contrast filling into the vein upon injection into the ica. Challenging access due to proximal bend just past carotid bifurcation and two tight bends proximal to the aneurysm. First accessed using the navien and phenom catheter with a plan to use a pipeline flex 4. 25x12. The doctor was unable to place the navien as far distal as he would have liked. When pushing the pipeline flex through the phenom around the tight bends proximal to the aneurysm the phenom catheter pulled back proximal to the aneurysm. The phenom and pipeline had to be removed without deployment. Access was reestablished using the sophia catheter and phenom with the sophia able to cross past the aneurysm for support. The 4x10 pipeline flex was advanced past the aneurysm and deployed. The pipeline was not fully apposed after deployment. When advancing the phenom back up over the pipeline delivery wire through the deployed pipeline it would not advance through the first turn before the pipeline. When the doctor went to adjust the pipeline delivery wire he realized that the wire had separated proximal to the first marker band. The proximal broken wire was removed and kept. The snare was then advanced up through the phenom but was not able to grab the proximal end of the broken wire. An attempt was also made to come from the left side across the acom to see if the distal end of the wire could be snared and removed through the left side, but the patient's acom was too small. Subsequent contrast runs into the right ica showed that the proximal wire tip had perforated the artery into the neighboring vein and contrast was visible in the vein. Patient was monitored and last contrast run was done with patient at a lower act level showing less contrast going into the vein. Plan is to monitor patient and possibly do a cta or another angio if needed. Broken wire goes from proximal to the pipeline to the ica terminus. Wire appeared to be stable with no movement. The pipeline and any accessory devices were prepared as indicated in the ifu. The separated device is in the distal ica from proximal to the pipeline placed to the ica terminus. Ancillary devices: cook shuttle sheath, navien. 058 x 115cm subsequently switched out for a sophia 5fr 115cm catheter microcatheter, phenom. 027 x 150cm, synchro 2 200cm, vascular solutions 4mm micro snare elite. Resistance was felt during advancement and during delivery. The resistance was moderate in severity. The patient was reported to be asymptomatic. Act at implantation was 411. The patient was on dual antiplatelet treatment. The aneurysm is in the right para-ophthalmic, right ica. The aneurysm was unruptured. The max diameter was 2. 2mm with a neck of 3. 4mm. The distal landing zone was 3. 6mm and the proximal was 4. 25mm. The vessel tortuosity was moderate.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9503529
MDR Text Key172428886
Report Number2029214-2019-01274
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-10
Device Lot NumberA826932
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/07/2019
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: 12/20/2019 Patient Sequence Number: 1
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