FDA Adverse Event Injury Summary report: N

HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

MDR report key: 10092394 · Received May 27, 2020

Report

Report Number: 2025587-2020-01717
Event Type: Injury
Date Received: May 27, 2020
Date of Event: April 9, 2020
Report Date: May 27, 2020
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Product Code: DYE
UDI-DI: 00643169594265
PMA / PMN Number: P980043
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 6 38RL32, SERIAL/LOT #: (B)(4), PMA #: K061127, UBD: 10-APR-2023, UDI#: (B)(4). PRODUCT ANALYSIS: THE DEVICES REMAINS IMPLANTED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCTS, 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 2 DAYS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE AND MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
556373	HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE	HEART-VALVE, REPLACEMENT	DYE	MEDTRONIC HEART VALVES DIVISION	T505C225		00643169594265

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Required Intervention