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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-425-12
Device Problems Break (1069); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2018
Event Type  malfunction  
Manufacturer Narrative
The device has been received. However, the device analysis has not yet been completed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the pipeline flex device separated from the pushwire on retrieval for repositioning. No patient injury occurred. All catheters were flushed and prepared per ifu and were advanced through max 88 sheath, past the aneurysm, with the microcatheter was placed in the m2. The pipeline device was flushed and introduced into the microcatheter and advanced past the aneurysm with the tip coil being taken to the m2 segment. Due to the tortuously of the vessel, more force than usual was required to advance the pipeline flex device. Upon unsheathed the pipeline device, exposing the distal part of the pipeline. The pipeline device appeared to be opening well, transitioned to pushing the device to expose more of the pipeline, the device stopped responding. When the pulling back on the delivery system to resheath and reposition the pipeline device, it was realized the pipeline device was not responding, and the pushwire had detached from the pipeline. The competitor guide catheter was advance over the microcatheter and re-captured the pipeline device and remove it with the microcatheter. A new microcatheter and new pipeline device were successfully delivered without incident. The ped was used off label as the aneurysm was smaller than recommended in the ifu. The devices were all prepared per the ifu.
 
Manufacturer Narrative
The device was returned for evaluation and the clinical observation was confirmed. As received, the pipeline flex delivery system stuck within microcatheter was returned for evaluation. The pipeline flex was then pushed out from the catheter lumen with difficulty. The distal hypotube was found to be stretched with the ptfe shrink tubing still intact. The pipeline flex pushwire appeared to be detached at the hypotube proximal to the wire weld. Kinks and bends were found on the pushwire at multiple locations from the proximal end. Additionally, the distal and proximal ends of the pipeline flex braid were found fully opened with moderately frayed. No other anomalies were observed. The surfaces of the detached pushwire were then sent out for sem and eds analyses. Based on the analysis findings and the sem/eds analyses, the distal wire of the pipeline flex delivery system was possibly detached due to tensile failure. In addition, the elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted. All products are 100% inspected for damage and irregularities during manufacture. The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection. Per our instructions for use (ifu): "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. 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. ¿ if information is provided in the future, a supplemental report will be issued.
 
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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
9492753836
MDR Report Key7608274
MDR Text Key111455740
Report Number2029214-2018-00548
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
Report Date 06/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/13/2021
Device Model NumberPED-425-12
Device Lot NumberA597670
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2018
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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