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

Model Number PED-325-16

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The pipeline flex braid remains implanted in the patient; the remainder was returned for evaluation.Evaluation is currently in progress.A follow up mdr will be submitted when evaluation is complete.

Event Description

Medtronic received report of pipeline flex migration during a procedure.It was reported that the patient was undergoing treatment of an unruptured, amorphous aneurysm at the left vertebra-basilar junction.The aneurysm measured 8mm max diameter and 5mm neck diameter.Landing zone artery size pre-procedure was 3.00mm distal and 3.75mm proximal.The vessel was moderately tortuous.The devices were prepared as per ifu.A continuous heparinized saline flush was used during the procedure.The pipeline flex was placed without issue.Upon retrieval of the guidewire, the pipeline flex migrated proximally into the vertebral artery.The physician did not make any attempts to retrieve the pipeline flex; the physician stated the device would eventually endothelialize.The physician suspected that the pipeline flex was undersized for the targeted vessel.Re-measurement on a different projection showed that the vessel was 4mm, as opposed to the original measurement of 3mm.Because of the migration, a second pipeline flex was placed.There was no report of patient injury as a result of this event.Post-procedure angiograph showed that the vertebral and basilar arteries were patent.

Manufacturer Narrative

Device evaluation: the pipeline flex delivery system was returned for evaluation without the pipeline flex braid as it was implanted in the patient.The pushwire appeared to be bent.No other anomalies were observed.Based on the analysis findings and event description, the report of pipeline flex migration after deployment could not be confirmed.The pushwire was found to be bent.However, the cause for damage could not be conclusively determined.All products are 100% inspected for damage and irregularities during manufacture.In this event, user error may have contributed to the migration issue.The pipeline flex was incorrectly sized, which may have subsequently caused the pipeline flex braid to migrate.Per pipeline flex instructions for use (ifu), the user should: ¿select an appropriately sized pipeline flex embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel.An incorrectly sized pipeline flex embolization device may result in inadequate device placement, incomplete opening, or migration.¿.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 5528120
• MDR Text Key: 41219520
• Report Number: 2029214-2016-00168
• 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,Followup,Followup
• Report Date: 02/29/2016

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 Expiration Date: 03/24/2018
• Device Model Number: PED-325-16
• Device Lot Number: A079096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 03/26/2016
• Supplement Dates Manufacturer Received: Not provided; 03/28/2016
• Supplement Dates FDA Received: 04/25/2016; 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• 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: 00042 YR