MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX EMBOLIZATION DEVIE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-450-16

Device Problem Activation Failure (3270)

Patient Problem Intimal Dissection (1333)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

This is a report for a similar device that is not marketed in the us.Suspect medical device - similar device brand name = pipeline flex w/shield technology model # = ped2-450-16.The device has not been received for evaluation.Therefore, the reported clinical experience cannot be conclusively determined.Further information has been requested.Should the reported device be received for evaluation or additional information is available, a follow up report will be filed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a pipeline flex embolization device with shield technology (ped2) did not open at the distal segment during a flow diversion procedure.The device was used for treatment of a patient's saccular cerebral aneurysm located at the right internal carotid artery.The distal and proximal landing zone artery size were 3mm and 4.2mm respectively.Vessel tortuosity was described as moderate.It was reported the device was prepared following the instruction for use.The ped2 was used with a non-medtronic microcatheter.After the ped2 was positioned distally to the aneurysm, the physician began to deploy the ped2 in a straight segment of the parent vessel.The distal segment of the ped2 did not open.The ped2 was resheathed followed by a 2nd attempt to deploy the ped2.The distal segment of the ped2 remained not opened.The physician unsheathed more of the ped2 braid to more 50%, but the situation did not changed.The physician then brought the distal access catheter closer to the ped2 and relieved the slack in the system followed by resheathing and unsheathing of the ped2.Three more attempts were made to deployed the ped2.As the distal segment of the ped2 remained not opened, this device was removed from the patient.It was reported the patient had injury to right internal carotid artery, howe ver, the detail condition of the injury was asked but not provided.A second ped2 was used to treat the patient.The post procedure angiograph was reported as good.

Manufacturer Narrative

The reported device was received and evaluated.As received, the pipeline flex embolization device with shield technology (ped2) braid was not attached to its pushwire.Both ends of the ped2 braid appeared opened with no damage.Further examination of the ped2 pushwire found no anomalies.Based on the product analysis, the report of the ped2 failed to open at the distal segment could not be confirmed.The patient's moderate vessel tortuosity could have been a factor that contributed to the reported issue, but actual cause of the clinical experience could not be conclusively determined or explained from product analysis.The ped2 instruct for use states, "precautions ¿ do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.".All devices are 100% inspected for damage and irregularities during manufacture.No evidence was found to suggest that the devices failed to meet specifications; therefore, manufacturing has been ruled out as a potential cause.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVIE
• 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: 7239147
• MDR Text Key: 99194765
• Report Number: 2029214-2018-00081
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2019
• Device Model Number: PED-450-16
• Device Lot Number: A283980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• 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: 55 YR