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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 PED2-500-35
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/29/2017
Event Type  malfunction  
Manufacturer Narrative
The device was implanted in the patient. 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. Linked with: 2029214-2018-00782. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that pipeline flow diverter was used, with proximal connection to a previously implanted pipeline flow diverter. However, there was shortening of the stent resulted in an entry and re-entry zone in both the proximal and the distal part of the diseased vascular segment, so that extension in a distal direction with additional pipeline flow diverter was necessary and a fred 5. 5/32 was then used in a proximal direction owing to the higher mesh density. The unruptured aneurysm was fusiform, in the right hemisphere, within the internal carotid artery (ica). The max diameter was 22mm with a dome height of 11mm. The distal parent artery was 5mm and 5. 5 mm proximately. The aneurysm was 30% partially thrombosed prior to the ped placement. Post device placement, there was significant stasis and class 3 residual aneurysm.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7853325
MDR Text Key119818983
Report Number2029214-2018-00783
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial
Report Date 09/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/11/2019
Device Model NumberPED2-500-35
Device Lot NumberA374339
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 Received08/15/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/11/2016
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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