MAUDE Adverse Event Report: MEDTRONIC MED TRONIC; PIPELINE FLOW DIVERTER PED325-16

Model Number PED-325-16

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/18/2016

Event Type  Injury  

Event Description

Physician inserted a pipeline flow diverter.Placement was satisfactory, however, the delivery wire fractured and could not be retrieved.There was unintended separation of the delivery wire device, resulting in a small wire remnant, which is left behind in the brain circulation, and secured with additional neuroform stenting, telescoping through the pipeline.The proximal end of the delivery wire was "trapped" between a stent and the vessel wall so that it could not migrate or cause a blood flow problem.

• Brand Name: MED TRONIC
• Type of Device: PIPELINE FLOW DIVERTER PED325-16
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 5616431
• MDR Text Key: 43992469
• Report Number: MW5061960
• Device Sequence Number: 1
• Product Code: OUT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2019
• Device Model Number: PED-325-16
• Device Catalogue Number: PED-325-16
• Device Lot Number: A210373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 104