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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC COVIDIEN PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-71400-25
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Paralysis (1997)
Event Date 03/25/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device will not be returned for evaluation as it was implanted in the patient; therefore without return of the device, no definitive conclusions can be drawn regarding the clinical observation. The event occurred in the patient post procedure and its cause was unknown. Attempts were made to obtain additional information, however, no further information was provided. User context may have contributed to this event. Pipeline embolization device instruction for use provided this instruction, "after the entire ped is deployed, advance the micro catheter through the ped making sure not to dislodge the ped. " same event as reported in mdr mfr: 2029214-2016-00242.
 
Event Description
Medtronic received information that the first device placed foreshortened more than expected and a second device was placed to cover the aneurysm neck. The devices dislodged from the point of overlap and fell into the aneurysm. Patient was reported to be hemiplegic. No further information was provided.
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key5596467
MDR Text Key106358724
Report Number2029214-2016-00243
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P100018.S004
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 03/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/12/2017
Device Model NumberFA-71400-25
Device Lot NumberA016802
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 Received03/27/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/13/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/21/2016 Patient Sequence Number: 1
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