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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-350-10
Device Problem Activation Failure (3270)
Patient Problem Fistula (1862)
Event Date 04/19/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline flex will not be returned for evaluation as it was implanted in the patient. The report that the pipeline flex did not completely open could not be confirmed. The cause of the issue could not be determined from the reported information. The location of the vessel rupture is proximal to the location of the pipeline implant. Vessel perforation is a known inherent risk of endovascular procedure and are documented in the pipeline flex embolization device instruction for use. Same event as reported in mdr mfr: 2029214-2016-00312. 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 report that a pipeline flex did not open during a procedure. In addition, the patient experienced a periprocedural vessel rupture. The patient was undergoing flow diversion treatment for an unruptured, saccular aneurysm. The aneurysm was located in the left internal carotid artery (ica) just proximal to the posterior communicating (pcom) artery. The aneurysm had a max diameter of 5mm and neck diameter of 2mm. Landing zone artery size was 3. 4mm distal and proximal. Vessel tortuosity was normal. The devices were prepared as indicated in the ifu. A continuous heparinized saline flush was used during the procedure. It was reported that a pipeline flex was deployed around a bend in the vessel. Upon deployment, the proximal end was not apposed to the vessel wall. The pipeline flex was never resheathed. The physician used a hyperglide balloon to angioplasty the proximal end open. A regular 1ml syringe was used with 50/50 contrast. The hyperglide was inflated twice without any issue. At the third inflation, the balloon caused a small rupture in the cavernous section of the ica that resulted in a carotid cavernous fistula (ccf). No medical or surgical intervention was required at the time. It was reported that the physician will monitor the patient for symptoms and decide whether treatment is needed. There was no report of patient symptoms as a result of this event. Post-procedure angiographic result showed slowing of flow into the aneurysm, as expected.
 
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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 Key5659703
MDR Text Key106358714
Report Number2029214-2016-00311
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 04/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/12/2018
Device Model NumberPED-350-10
Device Lot NumberA105736
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 Received04/19/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/13/2015
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: 05/17/2016 Patient Sequence Number: 1
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