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

Model Number PED-425-18

Device Problems Physical Resistance (2578); Activation Failure (3270)

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

Event Date 06/03/2017

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex will not be returned for evaluation as it was discarded by the customer.Product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Mdrs related to this event: 2029214-2017-00888 2029214-2017-00889.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 reports of pipeline flex incomplete opening during a procedure.The patient was undergoing treatment for an unruptured, amorphous aneurysm in the left internal carotid artery (ica) above the ophthalmic artery.Vessel tortuosity was severe.The devices were prepared as indicated in the ifu.The catheter was flushed during the procedure.It was reported that during the procedure, a pipeline flex was advanced through the catheter.High resistance was experienced when the pipeline flex was pushed through the catheter tip.About 1/3 of the pipeline flex was exposed out of the catheter tip, but could not be fully opened.High resistance was still experienced -the device could hardly be advanced and could not be resheathed.The system was removed from the patient.Ultimately, the procedure was completed using another manufacturer's device.There were no reports of patient injury in association with 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 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6704605
• MDR Text Key: 79907375
• Report Number: 2029214-2017-00888
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2019
• Device Model Number: PED-425-18
• Device Lot Number: A348274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2017
• Date Device Manufactured: 09/22/2016
• 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
• Patient Age: 63 YR