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

Model Number PED-350-20

Device Problem Activation Failure (3270)

Patient Problems Thromboembolism (2654); No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex remains implanted in the patient.The device will not be returned for evaluation, therefore the event could not be confirmed and an event cause could not be determined from the reported information.

Event Description

Medtronic received information that a pipeline flex appeared flattened during placement.The patient was undergoing treatment for an unruptured, fusiform and located in the left ophthalmic (c6) internal carotid artery (ica).At screening, the aneurysm had a dome of 1.6mm and neck diameter of 1.2mm.Parent artery diameter was 3.0mm distal and 3.6mm proximal to the aneurysm.It was noted that the pipeline flex had mild flattening proximal to an area of stenosis, possibly secondary to the narrowing.It was also noted that complete wall apposition was achieved.There were no reports of patient injury as a result of this event.The patient was discharged one day post-procedure with mrs and nihss of 0.

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.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Medtronic received additional event information: during the procedure, there was note to be nonocclusive in-stent thrombi formation within the ped and transient lack of contrast opacification of the left ophthalmic artery.The patient was administered intra-arterial integrilin (11mg x2) into the left internal carotid artery.Control angiograms and vasoct demonstrated complete resolution of the in-stent thrombi and complete patency of the left ophthalmic artery and normal appearance of the left choroidal blush following the administration of the integrilin.

• 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 ; 9496801224
• MDR Report Key: 5705586
• MDR Text Key: 46778498
• Report Number: 2029214-2016-00372
• 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,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2018
• Device Model Number: PED-350-20
• Device Lot Number: A054753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Date Device Manufactured: 02/07/2015
• 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: 67 YR