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

Model Number PED-375-14

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Rupture (2208)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

Date of event is approximate.The device will not be returned for evaluation as it was implanted in the patient.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.As per the 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 information that the device foreshortened and migrated distally approximately 6 weeks post treatment of a thrombosed cavernous clinoid aneurysm located in the right internal carotid artery.The patient was reported to have severe vessel tortuosity.The pipeline was placed at least 2-3 mm past the distal edge of the aneurysm and reportedly had full wall apposition.It was reported that the physician believed that a 14 mm long device was sufficient based on measurements but 16 mm would have been more suitable.It was further reported that the aneurysm ruptured and occurred post pipeline treatment; however the cause of the rupture was not provided.The patient was treated with coils.

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): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5719585
• MDR Text Key: 47190014
• Report Number: 2029214-2016-00392
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2017
• Device Model Number: PED-375-14
• Device Lot Number: 9971904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Date Device Manufactured: 07/16/2014
• 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: 72 YR