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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis, as it was implanted.Follow up attempts have been made however, our attempts have been unsuccessful.Investigation is ongoing.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the patient had been previously treated with a pipeline flex 5x18 device successfully.Upon follow up, the device had fallen back from its distal position, and was no longer covering the aneurysm neck.A second device was placed more distally to cover the neck.The date of incident is unknown.

• Brand Name: PIPELINE
• 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: 7334530
• MDR Text Key: 102246253
• Report Number: 2029214-2018-00195
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: No
• 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