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

Model Number PED-425-35

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Stroke/CVA (1770); Loss of consciousness (2418); Device Embedded In Tissue or Plaque (3165)

Event Date 08/06/2015

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as the tip coil remains inside the patient and the remainder of the device was discarded at the site.The complaint could not be confirmed, and the event cause could not be determined.Note: per pipeline flex instructions for use: do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.If high force or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.(b)(4).

Event Description

Medtronic (covidien) received report of pipeline flex tip coil break during treatment of a giant left internal carotid artery (ica) aneurysm.Patient had severely tortuous anatomy.Heparinized saline flush was used during the procedure.A pipeline flex was delivered to the distal end of a microcatheter and could not be pushed any further.The pipeline flex was removed by pulling it back through the microcatheter, leaving the microcatheter in place.The physician did not experience any more friction than usual during removal.A guidewire was then inserted through the microcatheter.When the guidewire exited the distal tip of the microcatheter, it was realized that the pipeline flex tip coil had broken off during removal and the guidewire had pushed it into the patient's vessel.The length of the broken segment is approximately 14-15mm.The physician did not feel the pipeline flex break during removal.It is believed that the tip coil broke at the solder joint, but there is no way to examine the broken segment to confirm.An attempt to tack down the tip coil with a stent was unsuccessful.The physician decided not to make any further attempts to retrieve the tip coil because it seemed locked into the patient's vessel; the physician did not want to risk dislodging it.The tip coil remains in the patient in a bend of the ica.The patient has since experienced a major stroke and is in the icu unresponsive.

Manufacturer Narrative

The lot history record review of the reported lot number showed no discrepancies that may have contributed to the reported experience.

Event Description

Medtronic (covidien) received additional information regarding the patient's condition.Patient had right hemiparesis upon awakening.Follow-up ct showed that pipeline flex tip coil remains in the left paraclinoid ica and effacement of the left lobe sulci that may correlate with acute stroke.

• Brand Name: PIPELINE FLEX 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 ; 9498373700
• MDR Report Key: 5010581
• MDR Text Key: 23270959
• Report Number: 2029214-2015-00897
• 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
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2018
• Device Model Number: PED-425-35
• Device Lot Number: A075313
• Other Device ID Number: 00836462015845180317A075313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• 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): Disability
• Patient Age: 74 YR