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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE EMBOL. DEVICE 3.75MM X 16MM INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC COVIDIEN PIPELINE EMBOL. DEVICE 3.75MM X 16MM INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-77375-16
Device Problem Delamination (2904)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2016
Event Type  Malfunction  
Manufacturer Narrative

The device has not been returned for evaluation; however, return is anticipated. Without return of the device, no definitive conclusions can be drawn regarding the clinical observation. Should the device be returned or additional information become available, a supplemental report will be submitted.

 
Event Description

Medtronic received information that upon removing the push wire from the plastic coil packaging, green layer coating fragments were observed detached from the metal core of the push wire. The device was not used on the patient. No patient injury was reported.

 
Manufacturer Narrative

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

The pipeline pushwire and braid were returned for evaluation. The dispenser coil and the catheter were not returned for evaluation. The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified. The pipeline braid was observed to be fully open with no damages. Dried blood was found on the tip coil, capture coil, and proximal bumper. The coating of the entire pushwire length was examined under the video inspection system (30x magnification) for coating integrity. Coating damage was observed at 5. 0cm to 37. 0cm from the proximal end. Based on the analysis findings clinical observation was confirmed. As the coating on the returned pushwire was observed to be damaged. The coating damage on the pushwire appeared to have been caused by mechanical scraping and abrasion by a metal torque device (pin vise) and/or rhv valve. The torque device and rhv were also not returned for evaluation; therefore any contributing factors from the torque device/rhv valve could not be determined. 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.

 
Event Description

Medtronic received additional information, that the device was used during the procedure. It was reported that the surgeon felt difficult pushing it up and removed from the patient. It was then noted that the green coating was observed detached from the push wire.

 
Event Description

Medtronic received additional information, that the aneurysm treated was located in the supraclinoid segment of the left internal carotid artery (ica).

 
Manufacturer Narrative

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

 
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Brand NamePIPELINE EMBOL. DEVICE 3.75MM X 16MM
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 Key5978896
MDR Text Key55693595
Report Number2029214-2016-00835
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeHK
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,Followup,Followup
Report Date 11/08/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/29/2018
Device MODEL NumberFA-77375-16
Device LOT NumberA113791
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/03/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/30/2015
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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