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U.S. Department of Health and Human Services

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

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MEDTRONIC COVIDIEN PIPELINE EMBOL. DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-77375-16
Device Problem Flaked (1246)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2016
Event Type  Malfunction  
Manufacturer Narrative

The device has not been returned for evaluation; without return of the device, no definitive conclusions can be drawn regarding the clinical observation. Attempts were made to obtain additional information, however, no further information was provided.

 
Event Description

Medtronic received information that physician didn䔠use the device because when it was removed from the package the "teflon" was falling off the "wire guide". It was reported that during flow-diversion treatment the device was introduced into the microcatheter and the "teflon" coverage was falling off the "wire guide. " no patient injury was reported.

 
Manufacturer Narrative

Related to correction/recall number: 2029214-10/7/16-001-r. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Search Alerts/Recalls

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Brand NamePIPELINE EMBOL. 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 Key5632685
MDR Text Key44449733
Report Number2029214-2016-00273
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 04/04/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2017
Device MODEL NumberFA-77375-16
Device LOT NumberA031361
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 Received04/04/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/15/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction Number2029214-10/7/16-001-R

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