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

Model Number PED-400-16

Device Problems Physical Resistance (2578); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation as it was discarded by the customer.The device was not returned for analysis, therefore the report of pipeline flex failure to open could not be confirmed, and the event cause could not be determined.It is possible that the patient¿s severely tortuous vessel anatomy may have contributed to the reported issue.Per our instructions for use (ifu): "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.¿ 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 report that a pipeline flex did not open during a procedure.The patient was undergoing treatment for an unruptured, saccular aneurysm in the right paraclinoid internal carotid artery (ica).The aneurysm max.Diameter was 21.5mm and neck width was 6.1mm.The vessel was severely tortuous.It is not known whether the devices were prepared as indicated in the ifu.It was reported that during deployment, the pipeline flex did not expand at the desired location due to the patient¿s tortuous anatomy.The pipeline flex was removed from the patient and discarded.Afterward, a new pipeline device was implanted in the patient.There were no reports of patient injury in connection with this event.

Manufacturer Narrative

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

• 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: 6517335
• MDR Text Key: 73562865
• Report Number: 2029214-2017-00508
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2018
• Device Model Number: PED-400-16
• Device Lot Number: A176431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Date Device Manufactured: 10/21/2015
• 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 Age: 54 YR
• Patient Weight: 51