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

Model Number PED2-425-20

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis as it was implanted in the patient.Since the device was not returned, we are unable to perform further root cause analysis.Per the instructions for use, choose a embolization device with labeled diameter that approximates the target vessel diameter.Select an appropriately sized embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel.An incorrectly sized embolization device may result in inadequate device placement, incomplete opening, or migration.All products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that at 3 month follow up, the flow diverter had migrated and was no longer covering the aneurysm neck.The patient is asymptomatic.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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 ; 9492753836
• MDR Report Key: 7041936
• MDR Text Key: 93068812
• Report Number: 2029214-2017-01272
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: PED2-425-20
• Device Lot Number: A351266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2016
• 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): Required Intervention
• Patient Age: 60 YR