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

Model Number FA-71300-25

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 03/14/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis; therefore the event cause could not be determined.Per pipeline instruction for use: "after the entire ped is deployed, advance the microcatheter through the ped making sure not to dislodge the ped.".

Event Description

Medtronic received information that the distal end of the pipeline accidentally dislodged into the aneurysm.The patient was treated for an unruptured, fusiform, wide-necked (14 mm) aneurysm located in the left vertebral artery aneurysm arising proximal of the pica.It was reported that the pipeline was initially deployed nicely across the aneurysm.Upon removal of the pushwire and advancement of the microcatheter to capture distal protective coil, the device was accidentally dislodged into the aneurysm.The physician decided to telescope another pipeline into the first device to cover the distal segment.The patient is doing fine as timely preventative action taken by physician.Post angiographic results showed slow flow within aneurysm with good stasis.No patient injury was reported as a result of this procedure.

Manufacturer Narrative

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

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• 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: 5570618
• MDR Text Key: 42428400
• Report Number: 2029214-2016-00217
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2018
• Device Model Number: FA-71300-25
• Device Lot Number: A174426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: 03/16/2016
• Supplement Dates FDA Received: 09/20/2017
• Date Device Manufactured: 10/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00048 YR