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

Model Number PED-375-12

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/24/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline flex will not be returned for evaluation as it remains implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patient post procedure and its cause is not known.

Event Description

Medtronic received report that a patient required retreatment after pipeline flex implantation.The patient received the pipeline flex implant to treat a saccular aneurysm in the right communicating (c7) internal carotid artery (ica).At the time of implantation, the aneurysm dome measured 5.2mm and neck diameter was 3.7mm.Approximately seven months post-procedure, the underwent retreatment reportedly due to "device migration." during the retreatment procedure, an additional pipeline flex device was implanted.There was no report of patient symptoms as a result of this event.

Manufacturer Narrative

Patient weight - correction.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.

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: 5739803
• MDR Text Key: 47892473
• Report Number: 2029214-2016-00416
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2018
• Device Model Number: PED-375-12
• Device Lot Number: A054197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• Date Device Manufactured: 02/06/2015
• 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: 66 YR
• Patient Weight: 68