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

Model Number PIPELINE

Device Problem Communication or Transmission Problem (2896)

Patient Problem Fistula (1862)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Article website: +http://casereports.Bmj.Com/content/2015/bcr-2015-011786.Long off label use: treatment of carotid¿cavernous fistula.Per instruction for use: the pipeline¿ 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.Information regarding the device model and lot numbers, patient weight, and procedure complications have been requested; however, the authors have indicated that the information cannot be provided.The device will not be returned fro analysis as it was implanted in the patient.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure complication.

Event Description

Medtronic (covidien) received information from literature review that a patient required another pipeline embolization device (ped) placement four months after the first ped implant due to persistent fistulous communication across the petrous cavernous junction.The patient was treated for a high flow, direct left carotid-cavernous fistula (ccf).A ped was deployed across the petrous-vernous carotid junction from a transarterial approach.A post-procedure angiogram showed near complete resolution of the ccf, with a few minor fistulous connections in the petrous segment of the internal carotid artery (ica).Four months later, a cerebral angiogram showed persistent fistulous communication across the petrous cavernous junction-aped was deployed into the left m1 segment of the middle cerebral artery in order to treat this abnormal communication.Seven months later, a repeat angiogram showed a completely remodeled ica and occlusion of the ccf.Citation: pradeep n, nottingham r, kam a, et al.Treatment of post-traumatic carotid-cavernous fistulas using pipeline embolization device assistance.Bmj case rep.2015 aug 25;2015.Pii: bcr2015011786.Doi: 10.1136/bcr-2015-011786.

• 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 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine 92618 ; 9496801224
• MDR Report Key: 5088479
• MDR Text Key: 26229766
• Report Number: 2029214-2015-05003
• 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: health professional,literatur
• Reporter Occupation: Physician
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PIPELINE
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2015
• 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): Required Intervention
• Patient Age: 00023 YR