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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-275-20
Device Problem Migration (4003)
Patient Problems Neurological Deficit/Dysfunction (1982); Therapeutic Response, Decreased (2271)
Event Date 01/31/2019
Event Type  Injury  
Manufacturer Narrative
The device was not returned as it was implanted. Attempts to gather additional event details have been made. However, our attempts have been unsuccessful. Since the device was not returned, we are unable to perform further 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 information that there was migration of the pipeline device after the procedure and that the patient experienced some symptoms approximately 1 ¿ 2 days post procedure. A computed tomography was performed and it showed that the pipeline had migrated. The patient had another procedure performed to retreat the aneurysm. It was noted that the pipeline was implanted in the intended location, but the cause of the migration was unknown. The status of the aneurysm was unruptured.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8395174
MDR Text Key137979232
Report Number2029214-2019-00165
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Model NumberPED2-275-20
Device Lot NumberA590525
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 Received03/13/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2018
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: 03/06/2019 Patient Sequence Number: 1
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