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

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

Patient Problem Ischemia (1942)

Event Type  Injury  

Manufacturer Narrative

Abstract citiation: f di maria, a gue´don, f clarencon et.Al."very late ischemic complications in flow diverter stents: a retrospective analysis of a single center series." 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.

Event Description

Medtronic received information through literature review that three patients (3.5%) treated with the pipeline embolization device presented a delayed acute ischemic stroke (2 cases of perforator/sidewall branch infarction and one thrombo-embolic stroke) with an average delay of 383 days (4 months; 1 year and 8 months; 1 year and 1 month, respectively).The aneurysmal locations were respectively: left sca, right achoa and left carotid-ophthalmic.Clinical outcome was satisfactory in all 3 cases (mrs 0-2).

• 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: 5780565
• MDR Text Key: 49124294
• Report Number: 2029214-2016-00535
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2016
• 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: 06/13/2016
• 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