MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-425-18

Device Problem Activation Failure (3270)

Patient Problem Fistula (1862)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as it was implanted in the patient.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Mdrs related to this report: 2029214-2016-01014.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during treatment of an aneurysm located in the left internal carotid artery (ica), two pipelines did not open.In addition, the carotid became occluded forming a cavernous carotid fistula.After further imaging and checking patency of the circle of willis the physician sacrificed the carotid artery.It was reported that the first ped-425-18 did not open proximally and the second device did not open distally as they were positioned in a bend.Proximal segment landed in a curve, slow flow was noted.A second ped-450-16 device was implanted and overlapped to extend the device into a straight segment, both pipelines remain in the patient.After deployment of the second device the carotid became occluded forming a ccf.The ccf was treated with coils and post angio showed carotid was coiled.The patient is currently doing fine.The aneurysm was unruptured and saccular, the max diameter is not known.The neck diameter was 4.5 (mm) and the distal landing zone was 4.0 mm and the proximal was 4.25 mm.The patient had moderate vessel tortuosity.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6101216
• MDR Text Key: 59835774
• Report Number: 2029214-2016-01013
• 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
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: PED-425-18
• Device Lot Number: A303456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Date Device Manufactured: 06/30/2016
• 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: 68 YR