FDA Adverse Event Injury Summary report: N

MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

MDR report key: 9878413 · Received March 25, 2020

Report

Report Number: 2025587-2020-00954
Event Type: Injury
Date Received: March 25, 2020
Date of Event: April 26, 2014
Report Date: March 25, 2020
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Product Code: DYE
UDI-DI: 00643169001633
PMA / PMN Number: P990064
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 9 00SFC26, SERIAL/LOT #: (B)(4), UBD: 31-AUG-2018, UDI#: (B)(4), PMA#: K093903 PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER. A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING AND 27MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PERMANENT PACEMAKER WAS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
342970	MOSAIC MITRAL BIOPROSTHETIC HEART VALVE	HEART-VALVE, REPLACEMENT	DYE	MEDTRONIC HEART VALVES DIVISION	310C27		00643169001633

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Required Intervention