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U.S. Department of Health and Human Services

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

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MEDTRONIC COVIDIEN PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-425-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 11/10/2016
Event Type  Injury  
Manufacturer Narrative
The device has been returned for evaluation and analysis of the device is anticipated.A supplemental report will be submitted upon completion.Mdrs related to this report: 2029214-2016-01124, 2029214-2016-01125, 2029214-2016-01126.
 
Event Description
Medtronic received information that during treatment of an aneurysm located in the right internal carotid artery (ica), a dissection, resulting in the placement of a stent, occurred within the right ica.Per the event report the dissection was likely a result of the number of passages made to deliver the device and the time of the procedure as the patient had severe vessel tortuosity.
 
Manufacturer Narrative
As received, the pipeline flex delivery system (ped-425-20) was returned stuck inside the distal segment of the microcatheter.The distal hypotube appeared to be stretched.The distal end of the pipeline braid was observed slightly frayed.The pushwire was found bent and kinked.The catheter body was found to have accordion damage.No other anomalies were observed.Based on the reported information and device analysis we are unable to definitively determine the cause for the reported experienced.However, it is possible that the ¿severe vessel tortuosity¿ may have contributed to ¿resistance¿ during delivery; subsequently causing the pipeline flex delivery system and the catheter to become damaged and stuck.However, the cause for resistance could not be determined.Additionally, the damages seen on the catheter body (accordioning), proximal wire (kinking/bending), pipeline braid (fraying) and hypotube (stretching); suggest excessive force was used.Furthermore, it was reported that the dissection of the right ica was likely a result of the number of attempts made to deliver the pipeline.We are unable to definitively determine the cause for the dissection.However dissection is listed as a potential complication in the pipeline flex ifu.Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal 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.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.¿ 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 Name
PIPELINE FLEX
Type of Device
INTRACRANIAL 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 Key6181616
MDR Text Key62602125
Report Number2029214-2016-01124
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/06/2018
Device Model NumberPED-425-20
Device Lot NumberA102199
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/17/2016
Initial Date FDA Received12/16/2016
Supplement Dates Manufacturer ReceivedNot provided
01/17/2017
Supplement Dates FDA Received02/03/2017
09/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient Weight60
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