MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 242

Device Problems Calcified (1077); Perivalvular Leak (1457)

Patient Problems Host-Tissue Reaction (1297); Aortic Regurgitation (1716); Atrial Fibrillation (1729); Calcium Deposits/Calcification (1758); Endocarditis (1834); Hematoma (1884); Hemorrhage/Bleeding (1888); Thromboembolism (2654); Vascular Dissection (3160)

Event Date 08/01/1988

Event Type  Injury  

Manufacturer Narrative

Citation: milano et al.Performance of the hancock porcine bioprosthesis following aortic valve replacement: considerations based on a 15-year experience.Ann thorac surg.1988 aug;46(2):216-22.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding 15-years of clinical experience with the hancock porcine bioprosthesis implanted in aortic valve replacement surgeries.All data were collected from a single center between march 1970 and december 1983.The study population included 196 patients (predominantly male, mean age 48 years), all of which were implanted with medtronic hancock porcine bioprosthesis (no serial numbers provided).Among all patients, per the physician/authors, there were 15 valve-related deaths due to: endocarditis in 5 patients, thrombo-embolic events in 5 patients, and low cardiac output at reoperation in 5 patients.No further details were provided regarding these deaths.Based on the available information medtronic product was directly associated with the death(s).Among all patients, adverse events included: thrombo-emboli, anticoagulation-related hemorrhage, endocarditis requiring intervention, paravalvular leak (pvl), atrial fibrillation, and permanent pacemaker implant.Additionally, there were ¿primary tissue failures¿ due to calcification, commissural/cusp damage, fibrous tissue overgrowth, or dissection of intracuspal hematoma.Based on the available information medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• Brand Name: HANCOCK AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8761680
• MDR Text Key: 150119226
• Report Number: 2025587-2019-02155
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P870078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 242
• Device Catalogue Number: 242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 48 YR