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

Model Number PED-400-35

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline flex will not be returned for evaluation as it remains implanted in the patient.The device was not returned for analysis; therefore the complaint could not be confirmed, and the event cause could not be conclusively determined.Per the instructions for use (ifu): "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.".

Event Description

Medtronic received report of pipeline flex migration after implantation.The pipeline flex had been implanted to treat three aneurysms in the right, cavernous internal carotid artery (ica): two small, sidewall aneurysms and one fusiform aneurysm.The device had been implanted in the intended location with full wall apposition.At the one-year follow-up, it was determined that the pipeline flex had moved proximal from its original landing zone.During the follow-up, it was observed that the two sidewall aneurysms had healed and were no longer present.However, the pipeline flex was not covering the fusiform aneurysm.The patient underwent retreatment to implant a second pipeline flex to fully cover the uncovered ica segment.At the time of retreatment, the aneurysm max.Diameter was 14mm and neck diameter was 10mm.Landing zone artery size was 5.6mm distal and 3.9mm proximal.Vessel tortuosity was moderate.Post-procedure angiographic result showed slight stagnation of contrast in the fusiform aneurysm.It was reported that the cause of the migration is not known.The physician did suggest that the healing of the diseased vessel could have resulted in changing of the flow dynamics, which allowed the pipeline flex to migrate proximally.There were no reports of patient symptoms in connection with this event.

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: 5851097
• MDR Text Key: 51292522
• Report Number: 2029214-2016-00655
• 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
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2018
• Device Model Number: PED-400-35
• Device Lot Number: A069819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• Date Device Manufactured: 03/07/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 41 YR