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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-425-16
Device Problems Break (1069); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/04/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline flex braid was implanted in the patient; the pushwire has not been returned for evaluation. The pushwire was not returned, therefore the reported event could not be confirmed. An event cause could not be conclusively determined from the reported information.
 
Event Description
Medtronic received report of pipeline flex pushwire break during a procedure. The patient was undergoing treatment for an unruptured, blister aneurysm in the dorsal supraclinoid internal carotid artery (ica). Neck diameter was 5mm. The landing zone artery size was 3. 57mm distal and 4. 26mm proximal. Vessel tortuosity was moderate. The devices were prepared as indicated in the ifu. It was reported that the pipeline flex was deployed. Resheathing was attempted, but the physician was unable to resheath the device into the microcatheter. The pipeline flex was instead deployed. At recapture of the delivery wire, it was reported that the wire broke at the ptfe strands. The wire and microcatheter were pulled from the patient together. There were no reports of patient injury in connection with this event.
 
Manufacturer Narrative
The pipeline flex pushwire was returned for evaluation. As received, it appeared that the pipeline flex pushwire was detached at the hypotube proximal to the wire weld. The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The pushwire was found to be bent at a section near the proximal end. The surfaces of the detached pushwire were sent out for scanning electron micrographic (sem) and energy dispersive spectroscopy (eds) analyses. Based on the reported event details, gross analysis, and sem/eds analyses, the reports of pipeline flex failure to resheath and pushwire detachment were confirmed. The distal wire of the pipeline flex delivery system was possibly detached due to tensile failure. From the damages observed on the returned proximal wire (bending) and hypotube (stretching), it appears there was excessive forced used (pushing and pulling). Per our instructions for use: "discontinue delivery of the device if high force or excessive friction is encountered. 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. 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. ¿ a review of the manufacturing process did not uncover any deficiencies in regards to the soldering process. In addition, the elemental analysis conducted through sem/eds analysis showed presence of soldering material thereby indicating that the soldering was conducted. It is possible that the patient¿s moderate vessel tortuosity may have contributed to the reported resistance during retrieval. However, the cause for resistance could not be conclusively determined. Additionally, the microcatheter was not returned, therefore any contributing factors from the microcatheter could not be assessed. All products are 100% inspected for damage and irregularities during manufacture.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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 Key6287214
MDR Text Key107528462
Report Number2029214-2017-00077
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-425-16
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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