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

Model Number PED-425-20

Device Problems Difficult To Position (1467); Activation Failure (3270)

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

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex will not be returned for evaluation as it was discarded by the customer.The device was not returned, therefore the event could not be confirmed.An event cause could not be conclusively determined from the reported information.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 paraophthalmic internal carotid artery (ica).The a neurysm maximum diameter was 20 mm and the neck diameter was 9 mm.The distal landing zone was 3.5 mm and the proximal was 4.20 mm.The patient had normal vessel tortuosity.The pipeline flex and accessory devices were prepared as indicated in the ifu.It was reported that the physician attempted to land the distal end of the pipeline flex braid just proximal to the a1; there was only 5mm between the distal edge of the aneurysm and the a1.The distal edge of the pipeline flex was slow to open.As a result, the pipeline flex and microcatheter "flopped" into the aneurysm missing the landing zone.The pipeline flex was removed and a new device was used to complete the procedure.Angiographic result post procedure showed stasis.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: 6026575
• MDR Text Key: 57360168
• Report Number: 2029214-2016-00896
• 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: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• 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-425-20
• Device Lot Number: A176432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• 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: 69 YR