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

Model Number PED-350-30

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The pipeline flex will not be returned for evaluation; the braid was implanted in the patient and the remainder was discarded by the customer.The reported event could not be confirmed and the event cause could not be conclusively determined.

Event Description

Medtronic received report that a pipeline flex push wire broke during a procedure.The patient was undergoing treatment for an aneurysm in the cavernous internal carotid artery (ica); side was not reported.Aneurysm was 6mm in diameter.Landing zone artery size was approximately 3.5mm.Vessel tortuosity was moderate to severe.A continuous heparinized saline flush was used, as per ifu.It was reported that the pipeline flex was advanced through the catheter with a normal amount of resistance.The pipeline flex was deployed one time.The physician was ¿wagging¿ the back end of the pipeline flex when the push wire broke.It was reported that the push wire broke in the general location of the distal hypotube, proximal to the wire weld.The physician was able to deploy the pipeline flex; the device was placed appropriately with full wall apposition.The push wire was removed from the patient.A gooseneck snare was put through the catheter to snare the piece of the push wire that remained in the patient.There was no report of patient injury as a result of this event.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 5518203
• MDR Text Key: 40945322
• Report Number: 2029214-2016-00156
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-350-30
• Device Lot Number: A186232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 03/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1