FDA Adverse Event Injury Summary report: N

COREVALVE

MDR report key: 3915808 · Received July 7, 2014

Report

Report Number: 2025587-2014-00446
Event Type: Injury
Date Received: July 7, 2014
Date of Event: October 21, 2013
Report Date: June 12, 2014
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Product Code: NPT
PMA / PMN Number: P130021
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCLUSION: CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR CATHETER-BASED) AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER (WITH THE RISK-BENEFIT RATIO IN FAVOR OF IMPLANT OF THE PERCUTANEOUS AORTIC VALVE). A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. THE DEVICE REMAINS IMPLANTED. (B)(4).

Description of Event or Problem · 1

MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED COMPLETE HEART BLOCK POST RAPID PACING. THE PATIENT WAS TEMPORARILY PACED AND THE RHYTHM RETURNED TO NORMAL RHYTHM AFTER PACING WAS DISCONTINUED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AT THAT TIME. ADDITIONAL INFORMATION WAS RECEIVED THAT AT SIX MONTHS POST-OPERATIVE THE PATIENT SHOWED ATRIAL FIBRILLATION WITH LEFT BUNDLE BRANCH BLOCK. SUBSEQUENTLY THE PATIENT WAS IMPLANTED WITH A PERMANENT PACEMAKER. CONDUCTION DISTURBANCES WERE RESOLVED WITH INTERVENTION. THE DEVICE REMAINS IMPLANTED WITH NO FURTHER ADVERSE PATIENT EFFECTS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
393583	COREVALVE	AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED	NPT	MEDTRONIC HEART VALVES DIVISION	MCS-P3-943

Patients

Seq	Age	Sex	Outcome	Treatment
1	00078 YR		Required Intervention