MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX 4.00MM X 18MM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-400-18

Device Problem Difficult To Position (1467)

Patient Problems Infarction, Cerebral (1771); Paresis (1998)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as it was implanted in the patient.We are unable to definitively determine the cause for the reported experienced.Furthermore, the cause for the post procedure complication is unknown.Mdrs related to this report: 2029214-2016-01054 2029214-2016-01055.

Event Description

Medtronic received information that during treatment of an aneurysm located in the cavernous segment of the ica, the pipeline (ped-350-16) moved back distally into the supraclinoid segment and was not opposed to the vessel wall.It was reported that the pipeline appeared to have been sized incorrectly.Therefore a second pipeline device (model and lot number unknown) was deployed to help hold the first device in place however, it also appeared to be too small.The snare retrieval device was used and the pipelines were telescoped.The anterior carotidal branch was covered by the pipeline.The flow in aneurysm was reduced and flow to distal vessels was good.After the procedure was complete the patient lost consciousness and an ischemic stroke was identified at the treatment site.In addition, the patient experienced left side weakness.The patient was later seen for a headache and continued left side weakness.It was later determined that the calibration of the system was off and had given incorrect measurements.The aneurysm max diameter was 6 mm and the neck diameter was 4mm.The distal landing zone was 3.1 mm and the proximal was 3.6 mm.The patient had moderate vessel tortuosity.

Manufacturer Narrative

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 additional information that a ct scan was performed and the device was shown to be open.It was reported that the patient's headache has since resolved.Furthermore, the patient was reported to have only a slight right sided arm weakness deficit, and is otherwise completely intact.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX 4.00MM X 18MM
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6126342
• MDR Text Key: 60846433
• Report Number: 2029214-2016-01055
• 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,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED-400-18
• Device Lot Number: A181201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• Is the Device Single Use?: 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; Disability
• Patient Age: 76 YR