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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patient post procedure and its cause was unknown.Citation: ki-su park, dong-hun kang, won-soo son, et al.¿a case of ruptured blood blister-like aneurysm treated with pipeline embolization device: clinical significance of fetal-type posterior communicating artery.¿ neurointervention.12:40-44; 2017 mdrs related to this report: 2029214-2017-00553 2029214-2017-00554.

Event Description

Medtronic received information through review of literature that there was a case of aneurysm regrowth following pipeline embolization device (ped) application for a ruptured blood blister like aneurysms (bba).It was reported that 10 days post ped deployment, dsa revealed intraneurysm contrast filling and regrowth.Additional treatments were planned, which included balloon angioplasty with the first ped was performed to achieve complete apposition to the internal carotid artery (ica) wall.Then, an additional ped was implanted within the previous ped for stronger flow diversion.However, contrast filling into the bba still remained after the procedure.Eventually coil trapping at the original of the fetal type posterior communicating artery (pcoa) was planned.A total of non-medtronic coils were deployed and dsa showed complete occlusion of the origin of the pcoa and no contrast filling into the bba from ica.Postoperative clinical course was uneventful.The patient was discharged without any neurological deficit.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC 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: 6520862
• MDR Text Key: 73665892
• Report Number: 2029214-2017-00553
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P100018.S004
• 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
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR