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

Model Number PED-250-10

Device Problem Difficult To Position (1467)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

The device was not retuned for evaluation as it remains in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation.

Event Description

Medtronic received information that the pipeline was bumped causing the distal end of the pipeline to fall into the proximal aneurysm as the tip coil proximal to the pipeline was being re-captured.The pipeline was implanted in the intended location with full wall apposition, but the distal end was left inside the dome of the aneurysm despite several attempts to re-gain access.Retrieval of the pipeline was not optimal; therefore, the pipeline was left in the patient.The physician plans to bring the patient back in two months to check the aneurysm.There were no patient symptoms 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 92703
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92703
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine 92618 ; 9496801224
• MDR Report Key: 6124699
• MDR Text Key: 60787357
• Report Number: 2029214-2016-01050
• 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: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: PED-250-10
• Device Lot Number: A303454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2016
• 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): Other
• Patient Age: 63 YR