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U.S. Department of Health and Human Services

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

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MEDTRONIC COVIDIEN PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-71400-35
Device Problems Flaked (1246); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2016
Event Type  Malfunction  
Manufacturer Narrative

The device will not be returned as it remains in the patient. Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.

 
Event Description

Medtronic received information that during treatment of an aneurysm located in the right side of the intracavernous internal carotid artery the middle segment of the device did not open. It was reported that the microcatheter reached to 20 mm of the neck of the aneurysm and the distal segment opened successfully however, as the physician released the device slowly a mild "kink" in the middle of the device was noted. The physician then repeated to increase and release tension but it did not reach the device to release the rest of the device. The device had good wall apposition and the physician pushed the guidewire, however the "kink" within the middle of the device could not be opened and remains in the patient. No patient injury was reported.

 
Manufacturer Narrative

The pipeline pushwire was returned within the microcatheter. The pipeline braid was not returned for evaluation as it was implanted in the patient. The pipeline pushwire was observed to be within a microcatheter with an rhv attached to the microcatheter hub and a torque device attached to the proximal section of the pipeline pushwire. The torque device and rhv were removed from the microcatheter and pipeline pushwire with no issues. For further examination, the pipeline pushwire was pushed through the microcatheter with no issues. Based on the analysis findings the clinical observation could not be confirmed as the pipeline braid was not returned. Therefore, we are unable to definitively determine the cause for the reported experience. A review of this device lot history record was conducted and no issues were identified that could have contributed to this event. In addition, ancillary findings not related to this event were observed during analysis. Coating damage was observed on the pushwire at 62. 0cm from the distal tip coil, and 28. 0cm to 30. 0cm from the proximal end. We are unable to definitively determine the cause of the coating damage observed. All products are 100% inspected for damage and irregularities during manufacture.

 
Manufacturer Narrative

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

 
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Brand NamePIPELINE
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 Key5645650
MDR Text Key44889830
Report Number2029214-2016-00290
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/08/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/10/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date01/22/2019
Device MODEL NumberFA-71400-35
Device LOT NumberA216381
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/16/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/23/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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