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

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

Patient Problems Infarction, Cerebral (1771); Neurological Deficit/Dysfunction (1982); Thrombosis (2100)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

Citation: hidenori oishi, kosuke teranishi, senshu nonaka, et al."symptomatic very delayed parent artery occlusion after flow diversion stent embolization" neurol med chir (tokyo) 56, 350¿353, 2016.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 a definitive cause could not be determined.

Event Description

Medtronic received information through review of literature that post pipeline treatment this patient suffered from symptomatic parent artery occlusion due to the in-stent thrombosis, 4 months after antiplatelet therapy discontinuation.The neurological examination showed motor aphasia and right sided hemiplegia.Diffusion weighted imaging showed new infarctions in the left frontal lobe cortex and centrum semiovale.Subsequent angiography confirmed the in-stent thrombosis with lift internal carotid artery occlusion and residual blood flow into the aneurysm.The patient was referred to rehabilitation center upon being discharged with mrs 3 due to the persisting consequences of stroke.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX
• 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: 6516337
• MDR Text Key: 73511873
• Report Number: 2029214-2017-00492
• 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
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• 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: 03/28/2017
• 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): Disability
• Patient Age: 72 YR