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

Model Number PED-300-20

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/25/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline flex will not be returned for evaluation as it remains implanted in the patient.The cause of residual aneurysm could not be conclusively determined from the reported information.

Event Description

Medtronic received report that a patient underwent retreatment one year after pipeline flex implantation.The patient reportedly was retreated due to residual aneurysm.There were no reports of patient symptoms in connection with this event.The patient had received the pipeline flex to treat a fusiform aneurysm in the right v4 vertebral artery.The aneurysm dome was 6.1mm and neck diameter was 5.4mm.There were no device issues noted during the implantation procedure.

Manufacturer Narrative

Additional information the customer¿s report of pipeline flex migration after deployment could not be confirmed and the event cause could not be determined.It is possible that the braid under-sizing may have contributed to the reported issue.Per our instructions for use (ifu): ¿select an appropriately sized ped such that its fully expanded diameter is equivalent to that of the largest target vessel diameter.An incorrectly sized ped may result in inadequate device placement, incomplete opening, or distal migration.¿ 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 event information: one year post-implantation, the patient was found to have residual aneurysm measuring 5mm wide, 6.2mm length, and 5.75mm base.The site noted ¿device migration¿ as the reason for retreatment.Per the procedure notes, the pipeline flex was in position and well-apposed to the vessel wall.The patient elected to undergo endovascular treatment in which two additional pipeline devices were implanted.After placement of the two pipeline devices, there was continued flow within the right pica and significantly stagnated flow within the pica aneurysm.

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: 6012274
• MDR Text Key: 56914703
• Report Number: 2029214-2016-00880
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2018
• Device Model Number: PED-300-20
• Device Lot Number: A061515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Date Device Manufactured: 02/20/2015
• 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: 72 YR