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

Model Number PED-425-25

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 10/27/2015

Event Type  Injury  

Manufacturer Narrative

The pipeline flex will not be returned for evaluation as it remains implanted in the patient.The device was not returned, therefore the reported event could not be confirmed.An event cause could not be conclusively determined from the reported information.

Event Description

Medtronic received report of pipeline flex migration during a procedure.The patient was undergoing flow diversion treatment of a cerebral aneurysm.It is not known whether the vessel was tortuous.The microcatheter was delivered to the distal m1 middle cerebral artery (mca).The pipeline flex was prepared, delivered to the tip of the microcatheter, and the protection sleeve was deployed.It was reported that the physician attempt to resheath the device, but was unable to due to resistance.The pipeline flex system was pulled back until it was distal to the posterior communicating (pcom) artery, which was the implantation site.The physician tried to deploy the device completely, but resheathing was still difficult.The physician was able to resheath the device to the resheathing marker, despite resistance.The pipeline flex was deployed completely.It was reported that when advancing the microcatheter to the distal end of the pipeline flex, foreshortening occurred.In addition, the pipeline flex had partially migrated into the aneurysm.For that reason, an additional pipeline flex device was implanted.Angiographic images were taken to confirm proper deployment.The procedure was completed.The patient is reportedly fine.There have been no reports of patient symptoms as a result of 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: 6101161
• MDR Text Key: 59835219
• Report Number: 2029214-2016-01010
• 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,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2018
• Device Model Number: PED-425-25
• Device Lot Number: A069399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2016
• Date Device Manufactured: 03/06/2015
• 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