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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN, IRVINE PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-350-18
Device Problems Break (1069); Activation Failure (3270)
Patient Problems Intimal Dissection (1333); Paresis (1998)
Event Date 09/02/2017
Event Type  Injury  
Manufacturer Narrative
Outcome attribute to adverse event: intervention required. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient was treated with stent and coil for the reported internal carotid artery dissection. The pipeline flex shown on the reported photos was pull out from the microcatheter after the pipeline and microcatheter set was removed from the patient. The fractured tip coil was inside the microcatheter. Corrected information was also received indicating there was no report of pipeline device failed to open. The device was stuck in the microcatheter and never deployed.
 
Manufacturer Narrative
The pipeline flex was returned for evaluation with the catheter. As received, the pipeline flex pushwire was found to be separated into two segments (distal and proximal). The distal broken segment of the pushwire was found stuck inside distal segment of the catheter. The proximal segment of the pushwire was found outside of the catheter. For further examination, the distal broken segment was pushed out of the catheter lumen with difficulty. The pushwire was appeared to be separated approximately 2cm from the distal tip coil (proximal to the dps sleeves). The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The distal end of the pipeline flex braid was found fully opened with moderate fraying; the proximal end of the braid was found fully open with no damage. The pushwire was found to be bent approximately 25cm from the proximal end. The broken end of the pushwire was sent out for sem analysis. Based on the analysis findings, event description, and sem analysis, the report of pipeline flex pushwire separation was confirmed. The fracture features indicate torsional overload failure. From the damages seen on the proximal wire (bending), braid (fraying) and hypotube (stretching), it appears there was high force used (pushing and pulling). It is likely these damages occurred when the customer continue to advance/retrieve the pipeline flex delivery system through the micro catheter despite severe resistance. Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is enco untered. 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 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. ¿ the review of lot history records shows that the finished device has met all manufacturing requirements and specifications. All products are 100% inspected for damage and irregularities during manufacture. 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
Photo received with unidentified used pipeline flex device with detached tip coil and partially opened pipeline. Information has been requested regarding this photographed pipeline. Reply is still pending. The reported device has not been received. The product was not evaluated, therefore the reported event could not be confirmed. The cause of the event could not be conclusively determined from the available information. Should the device be received for evaluation, new information shall be submitted in a follow up report. Pipeline flex embolization device instruction for use cautions: " if high forces or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance, remove device and micro catheter simultaneously. Advancement of the pipeline¿ flex embolization device against resistance may result in damage or patient injury. " linked mdr's 2029214-2017-01200, 2029214-2017-01201, 2029214-2017-01202, 2029214-2017-01203. 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 information that a patient had right internal carotid artery dissection and hemiparesis associated with an aneurysm embolization procedure. A pipeline flex device was used with a microcatheter for the treatment of the patient's saccular aneurysm located at the right internal carotid artery at ophthalmic segment. The aneurysm measured 6mm in max diameter and 4. 10mm in neck diameter and the distal and proximal landing zone artery sizes were 3. 4mm and 3. 7mm respectively. Vessel tortuosity was described as normal. It was reported the devices were prepared following the ifu. When the pipeline flex was advanced via the microcatheter, severe resistance was met. It was further reported force was applied during the delivery of the pipeline device. The proximal end of the pipeline delivery wire kinked. The pipeline device was locked up at the distal segment of the microcatheter. The devices were removed from the patient. Photo received with unidentified used pipeline flex device with detached tip coil and partially opened pipeline.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN, IRVINE
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN, IRVINE
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key6992266
MDR Text Key107093668
Report Number2029214-2017-01200
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P100018.S011
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,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/23/2019
Device Model NumberPED-350-18
Device Lot NumberA380477
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2016
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: 10/31/2017 Patient Sequence Number: 1
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