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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-450-35
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Perforation (2001)
Event Date 04/26/2016
Event Type  Death  
Manufacturer Narrative
The pipeline flex was implanted in the patient and will not be returned for evaluation. The reported event could not be confirmed and the cause of the event could not be conclusively determined. Aneurysm rupture is a known inherent risk of flow diversion procedure and is documented in the pipeline flex instruction for use. It should be noted that pipeline flex instructions for use provides the following guidance, "after the entire pipeline flex embolization device is deployed, advance the micro catheter through the device making sure not to dislodge the braid. When the micro catheter tip is distal to the pipeline flex embolization device, retract the delivery wire into the micro catheter tip. " all mdr's related to this event: 2029214-2016-00332, first pipeline flex (ped-450-35) 2029214-2016-00333, second pipeline flex (ped-475-35) 2029214-2016-00334 ¿ third pipeline flex (ped-500-20).
 
Event Description
Medtronic received report of aneurysm rupture during a pipeline flex procedure. The patient was undergoing flow diversion treatment of an unruptured, saccular aneurysm in the right paraclinoid internal carotid artery. The vessel was reportedly not tortuous. Max. Diameter was 18mm and neck width was approximately 8mm. Landing zone artery size was 3. 8mm distal and 4. 8mm proximal. All devices were prepared as indicated in the ifu. It was reported that three pipeline flex devices were placed overlapping one another. The devices were placed in a vessel curve. It was reported that the physician chose to implant three overlapping devices due to the patient's vasculature, but an exact reason was not provided. The first pipeline flex (ped-450-35) was placed most distally, then a pipeline flex (ped-475-35) more proximally, and a third pipeline flex (ped-500-20) was placed most proximally. After placement of the third pipeline flex, the physician advanced the catheter to capture the delivery wire, but the catheter advanced in an unintended direction. In addition, the physician noticed that the first and second pipeline flex devices no longer overlapped. After some difficulty, the physician was able to advance the catheter distally and took a contrast image, which showed the aneurysm was ruptured. The reason for rupture could not be identified. Coils were used to pack the ruptured aneurysm. Peripheral artery occlusion of the ica was also performed. The procedure was converted to an open surgery. Details of the open surgery are not available, but it was likely decompression. The patient passed away five days post-procedure. A cause of death was not identified.
 
Manufacturer Narrative
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.
 
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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 Key5672361
MDR Text Key45685029
Report Number2029214-2016-00332
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 04/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/20/2018
Device Model NumberPED-450-35
Device Lot NumberA150539
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/21/2015
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: 05/23/2016 Patient Sequence Number: 1
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