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

Model Number PED-425-20

Device Problem Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Date 10/29/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Endoleak the device will not be returned as it remains in the patient; therefore the cause of the clinical observation could not be definitively determined.Additionally, implant in the basilar artery is off label use and stent placement inside the pipeline is also off label use.Reference mfr report number: 2029214-2015-05157.

Event Description

Medtronic received information that a potential endoleak was noted distally.During treatment of a large wide neck saccular unruptured aneurysm located off of the basilar trunk this device was deployed and placed nicely across the aneurysm neck keeping in the first pipeline flex within the aneurysm.The max diameter was 15mm and the neck width was 10mm.The distal landing zone was 3.60mm and the proximal was 4mm.After subsequent runs a potential endoleak was identified.The physician then decided to use a stent to get better apposition through the middle portion of the device which was across the aneurysm neck to resolve the endoleak.The stent was then removed.Dapt treatment was administered.Immediate results showed slow flow.The patient was doing well post procedure and the physician believed the endoleak would resolve over time.No serious injury was reported as a result of this event.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTORNIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5244174
• MDR Text Key: 31966493
• Report Number: 2029214-2015-05158
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/22/2018
• Device Model Number: PED-425-20
• Device Lot Number: A077457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/23/2015
• Date Device Manufactured: 03/23/2015
• 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: 00059 YR