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

Model Number PED-375-16

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 12/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned; therefore, no definitive conclusion can be drawn regarding the clinical observation.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.

Event Description

Medtronic received information that the pipeline flex migrated while attempting reaccess the device.It was reported that device was placed at least 2-3 mm past the distal edge of the aneurysm and initially looked like it was covered, but when the physician did a run after deployment, it didn't have the minimum neck coverage.The physician attempted several times to reaccess the device, but was unsuccessful and in doing so caused the device to move proximally and not completely cover the neck of the aneurysm.Another device was deployed.There was flow in the internal carotid artery and the physician decided to stop treatment at this time.No patient complications were reported, patient is doing well.

• Brand Name: PIPELINE FLEX 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: 5337458
• MDR Text Key: 34735503
• Report Number: 2029214-2015-05246
• 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
• Report Date: 12/09/2015

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-375-16
• Device Lot Number: A079254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/31/2015
• 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: 00043 YR
• Patient Weight: 122