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

Model Number PED-325-14

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

The flow diverter was not returned for evaluation as it was implanted in the patient.Based on the images, the report of migration after deployment issue was confirmed.It is possible that the patient¿s moderate vessel tortuosity may have contributed to the reported issue.However, the cause of the device migration cannot be reliably determined.Per our instructions for use (ifu): do not use the embolization device in vessel diameters that are larger than the labeled diameter.Select an appropriately sized embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel.An incorrectly sized embolization device may result in inadequate device placement, incomplete opening, or migration.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.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 report that on the 2 years follow up angiogram, the flow diverter had foreshortened (migrated) and was now proximal to the neck of the aneurysm with no neck coverage, and blood flow was seen going into the aneurysm.The aneurysm is in the left ica.It is unruptured and amorphous in shape.The anatomy is moderate in tortuosity.The patient is on dual antiplatelet therapy.No patient injury was reported.

Manufacturer Narrative

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 ; 9492753836
• MDR Report Key: 6429985
• MDR Text Key: 70765527
• Report Number: 2029214-2017-00214
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2018
• Device Model Number: PED-325-14
• Device Lot Number: A065428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2015
• 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: 45 YR
• Patient Weight: 79