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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-400-25
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2019
Event Type  Injury  
Manufacturer Narrative
The pipeline device will not be returned for evaluation as it was implanted in the patient. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information a report of pipeline flex movement during placement. The patient was undergoing embolization treatment for a small unruptured saccular aneurysm located in ophthalmic segment, measuring 8mmx5mm, landing zone distal 2. 7mm proximal 3. 9mm. The vessel was observed severely tortuous. The catheter was flushed as indicated in the ifu. It was reported that this was a left para ophthalmic segment aneurysm planned for flow diverter. The microcatheter was placed in the distal m2 branch and pipeline 4x25 was taken through and started deploying just below the ica bifurcation. The distal landing was correct as per the plan just below the ica bifurcation. Continued to deploy the device slowly, while device started to open at the neck of the aneurysm, the distal device has fallen no adequate support of device was there above aneurysm neck. So physician decided to resheath the device. While resheathing the microcatheter along with device suddenly jumped into distal m2 segment. When physician tried to retrieve the device into microcatheter, only delivery wire of the device was seen moving into microcatheter and no movement in the device. Now physician had tried to pull the microcatheter and device together as a system , while pulling as a system the device could not be retrieved and got deployed form m2 to mid m1 of left ica. Now physician had deployed second device 4. 25x25 by overlapping the first device and covered till the proximal segment of aneurysm. There were any patient symptoms or complications associated with this event. No patient injury was reported.
 
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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
7635263305
MDR Report Key8480623
MDR Text Key140885343
Report Number2029214-2019-00281
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
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
Report Date 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/20/2021
Device Model NumberPED-400-25
Device Catalogue NumberPED-400-25
Device Lot NumberA648522
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2018
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: 04/03/2019 Patient Sequence Number: 1
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