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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX WITH SHIELD INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-425-16
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Patient Problems Perforation (2001); No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2018
Event Type  malfunction  
Manufacturer Narrative
The device was not returned, as it was implanted in the patient. Follow up attempts have been made to obtain additional information. 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 report that the guidewire was used to assist in opening pipeline device. There was also report of a stent being used during procedure, due to right carotid artery dissection.
 
Manufacturer Narrative
We have subsequently received additional information therefore are providing an updated report. From the new information received there has been no allegation of a device malfunction. All products are 100% inspected for damages and irregularities during manufacture. This event no longer fits the criteria for mdr reporting. Updated device code. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the guidewire was used only to optimize wall apposition of the pipeline device. No patient injury occurred.
 
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Brand NamePIPELINE FLEX WITH SHIELD
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 Key7522705
MDR Text Key108559592
Report Number2029214-2018-00433
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeHU
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 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/04/2020
Device Model NumberPED2-425-16
Device Lot NumberA455931
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 Received05/30/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/05/2017
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: 05/17/2018 Patient Sequence Number: 1
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