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

Model Number PED-500-14

Device Problem Activation Failure (3270)

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

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

The reported device has not been received for evaluation.Therefore, the cause of the reported event cannot be conclusively determine with information available.Should the device be received and evaluated.Additional information will be provided in a follow-up reported.

Event Description

Medtronic received information that a pipeline flex embolization device (ped) did not open at the distal segment during a flow diversion procedure.The ped was used to treat the patient's previously coiled amorphous aneurysm located at the internal carotid artery.It had a max diameter of 12mm and a neck width of 6mm.Vessel tortuosity was described as moderate.It was reported the ped was prepared as indicated in the instruction for use.The distal segment of ped was placed at a bend.At deployment, the distal segment of the ped did not open after more than 50% of the ped braid was unsheathed.The ped was removed with the microcatheter from the patient.New flow diverter was used to complete the procedure.No patient injury reported.

Manufacturer Narrative

Additional information, device evaluation the reported pipeline flex embolization device (ped) was received for analysis.As received, the ped was within the lumen of a microcatheter.No issue was encountered pushing the ped out of the microcatheter for further examination.Upon exiting the microcatheter, the ped braid was found fully opened.Damages, severe fraying at the distal segment and slight fraying at the proximal segment, were noted on the ped braid.No other anomalies were observed.Based on the findings, the report of ped braid "failure to open at the distal segment" could not be confirmed.The patient's moderate vessel tortuosity and damaged braid might have contributed to the reported issue.However, the actual cause of the reported clinical experience could not be determined.All products are 100% inspected for damage and irregularities during manufacture.No evidence was found to suggest that the devices failed to meet specifications the ped instruction for use states, "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.¿ if information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• 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: 7143522
• MDR Text Key: 95794141
• Report Number: 2029214-2017-01376
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Model Number: PED-500-14
• Device Lot Number: A517483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2017
• 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: 49 YR
• Patient Weight: 70