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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); Retraction Problem (1536); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2018
Event Type  Injury  
Manufacturer Narrative
The pipeline flex braid will not be returned for evaluation as it was implanted in the patient. The pipeline flex delivery system has not been returned for evaluation. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report of pipeline flex pushwire break during a procedure. The patient was undergoing flow diversion treatment for an unruptured, saccular aneurysm in the left internal carotid artery (ica). Vessel tortuosity was described as normal. The aneurysm had a max. Diameter of 3. 29mm and neck diameter of 3mm. The landing zone artery size was 3. 4mm distal and 4. 5mm proximal. The devices were prepared as indicated in the ifu. During the procedure, the pipeline flex was reportedly deployed without difficulty. The physician reportedly saw sub-optimal wall apposition in the proximal section of the pipeline flex, but went ahead with deployment. At recapture of the pipeline flex delivery system, the physician attempted to advance the catheter over the pushwire, but was not able to. Instead, the catheter and pipeline flex pushwire were withdrawn from the patient together. After removal, it was observed that the distal section of the pushwire remained in the artery. Another physician arrived who used a balloon to angioplasty the proximal section of the pipeline flex open. Afterward, the physician used a gooseneck snare to capture the pushwire piece that had detached. The angiographic result post-procedure was good. The patient is reportedly fine.
 
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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 Key7281373
MDR Text Key100401883
Report Number2029214-2018-00119
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 02/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2018
Device Model NumberPED-425-16
Device Lot NumberA133593
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 Received02/01/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/15/2015
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: 02/19/2018 Patient Sequence Number: 1
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