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

Model Number FA-71450-35

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/19/2015

Event Type  Injury  

Manufacturer Narrative

The lot history record of the reported lot number was reviewed and no discrepancies that might have caused the reported event were noted.The pipeline device will not be returned for evaluation as the tip coil remains in the patient and the remainder was discarded at the site.The complaint could not be confirmed, and the event cause could not be determined.Per pipeline instructions for use: "the pipeline (tm) embolization device (ped) is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments." in this case, the pipeline embolization device was used to treat a vertebral artery aneurysm.

Event Description

Medtronic (covidien) received report that a pipeline tip coil detached and remains in the patient.The patient was being treated for an unruptured fusiform aneurysm in the left vertebral artery.At deployment, the physician rotated the pushwire five times to detach.As the pipeline was being deployed, the tip coil could not travel further due to vessel terminus and the tip coil detached into the aneurysm.Detached segment was 15mm in length.A second pipeline was used to trap the tip coil.Post-procedure angiography shows that the tip coil is trapped mostly in the aneurysm with a portion trapped on vessel wall.The patient is reportedly in normal condition.

• Brand Name: PIPELINE 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: 5064400
• MDR Text Key: 25278686
• Report Number: 2029214-2015-00974
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2016
• Device Model Number: FA-71450-35
• Device Lot Number: 9820168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2013
• 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 Age: 59 YR