MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-325-16

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

The device remains implant inside the patient.The reported ped pushwire has not been returned for evaluation.Therefore, the cause of this clinical experience cannot be conclusive determined.Should the product be returned for analysis, a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the pushwire of a pipeline flex embolization device (ped) broke inside the patient during a flow diversion procedure.The device was used to treat a pediatric patient's fusiform aneurysm located at the left internal carotid artery measured 3.6mm in max diameter.The landing zone vessel diameters were 2.7mm distally and 2.84mm proximally.Vessel tortuosity was described as minimal.This patient has history of tuberous sclerosis complex which causes frequent growth of cysts and tumors.The patient needs frequent mri for his lifetime.It was reported the device was prepared following the instruction for use.No friction was encountered when the ped was advanced through the micro catheter.The ped was never resheathed prior to the reported event.During the deployment of the ped in the anterior cerebral artery, the physician attempted to resheath the ped.At this point, the delivery wire broke at the proximal marker, so the ped was deployed.The ped landed on the desired location with adequate wall apposition.Attempt was made to snare the broke wire from the patient.The retrieval effort was unsuccessful.The snare device also moved the deployed.Ped distally.As a result, a second ped was placed for the patient.The fractured delivery wire was left inside the patient.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient was discharge with instruction of no mri until contacted by the physician.

• Brand Name: PIPELINE FLEX
• 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: 7144377
• MDR Text Key: 95722538
• Report Number: 2029214-2017-01379
• 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: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2019
• Device Model Number: PED-325-16
• Device Lot Number: A210313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• Date Device Manufactured: 01/11/2016
• 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: 10 YR
• Patient Weight: 31