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U.S. Department of Health and Human Services

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

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MEDTRONIC COVIDIEN PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-77325-20
Device Problems Break (1069); Positioning Failure (1158); Kinked (1339); Stretched (1601)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/25/2016
Event Type  Injury  
Manufacturer Narrative
Updated: device codes. The flow diverter¿s pushwire and the mechanical thrombectomy were returned for evaluation. The flow diverter¿s braid and microcatheter were not returned. The flow diverter¿s capture coil was observed to be stretched and bent with the flow diverter¿s pushwire being within. No breaks or separations were found on the pipeline pushwire. No device fractured parts were found within the mechanical thrombectomy stent device. No damages were found on the tip coil, proximal bumper, or the mechanical thrombectomy device. Coating damage was observed on the distal and the proximal segments of the pushwire. No other anomalies were observed. However, the cause for the damage on the capture coil could not be determined. Based on the analysis findings and the reported event details, the report of stuck in stuck inside capture coil and pushwire break/separation issues was not confirmed. The cause for the reported experience could not be determined as the flow diverter¿s braid was not attached to the capture coil and the pushwire was found to have no breaks or separations. The damages found on the capture coil and the flow diverter¿s pushwire may have contributed to the reported device tuck inside capture coil issue. The coating damage on the proximal end of the pushwire appeared to have been caused by mechanical scraping and abrasion by a metal torque device (pin vise) and/or rhv valve. All products are 100% inspected for damage and irregularities during manufacture. Per our instructions for use (ifu): select an appropriately sized flow diverter such that its fully expanded diameter is equivalent to that of the largest target vessel diameter. An incorrectly sized flow diverter may result in inadequate device placement, incomplete opening, or distal migration. If high force or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance. Remove device and microcatheter simultaneously. Advancement of the flow diverter against resistance may result in device damage or patient injury. Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel. Detachment can be facilitated by slowly rotating the delivery wire in the clockwise direction and/or manipulating the microcatheter by locking down the delivery wire and moving both as a system. If the capture coil tip of the delivery system becomes stuck in the mesh of a delivered flow diverter, rotate the wire clockwise while advancing the wire to try to release it, then slowly pull back on the delivery wire. Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. 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.
 
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. Should the device be returned or additional information become available, a supplemental report will be submitted.
 
Event Description
Medtronic received information that during treatment of an aneurysm located in the ophthalmic segment of the internal carotid artery (ica), the distal segment of the device would not open and the distal segment of the push wire was fractured. It was reported the distal end of the pipeline device did not open, despite making adjustments and rotating the push wire. It was further reported that resistance was encountered within the microcatheter during delivery and the push wire was not rotated more than 10 times. The pipeline device was removed by withdrawing into the guidecatheter. It was then noted that the distal segment of the push wire was fractured. The physician removed the fractured push wire segment successfully using a mechanical thrombectomy device. No broken fragments remained inside the patient; the surgery was prolonged about an hour. A new pipeline was used and released successfully. No patient injury was reported.
 
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Brand NamePIPELINE EMBOLIZATION 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
9492753836
MDR Report Key5985754
MDR Text Key106345368
Report Number2029214-2016-00841
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 07/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/26/2018
Device Model NumberFA-77325-20
Device Catalogue NumberFA-77325-20
Device Lot NumberA049104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2015
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: 09/28/2016 Patient Sequence Number: 1
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