MAUDE Adverse Event Report: HEART VALVES SANTA ANA HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T505

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bradycardia (1751); Stroke/CVA (1770); Endocarditis (1834); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Pericardial Effusion (3271); Cardiovascular Insufficiency (4445); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

Citation: hribernik et al.Comparative analysis of surgical and percutaneous pulmonary valve implants over a 20-year period.Eur j c ardiothorac surg.2021 aug 18;ezab368.Doi: 10.1093/ejcts/ezab368.Earliest date of publish used for date of event.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 comparison of surgical and transcatheter pulmonary valve implants over a 20-year period.All data were collected from a single center between august 1998 to april 2020.The study population included a total of 493 patients (predominantly male, mean age 26.3 years, mean weight 67.1 kg) with 365 patients in the surgical group and 128 patients in the transcatheter group.Multiple manufacturer¿s devices were implanted in the study population.Among all patients 80 were implanted with a medtronic device: in the surgical group 14 received a hancock aortic valve and 2 received a medtronic contegra conduit, and in the transcatheter group 64 received a melody bioprosthetic valve.No unique device identifier numbers were provided for these devices.Among all patients, 4 deaths (4 surgical and 0 transcatheter) occurred within 30 days and 22 deaths (16 surgical and 6 transcatheter) occurred during the follow-up period.Based on the available information medtronic product was not directly associated with the death(s).Among patients in the surgical group, adverse events included: endocarditis (median time 13 months post-implant), sternal infection/ dehiscence, mediastinal hematoma, pericardial effusion requiring pericardiocentesis, iatrogenic ventricular injury requiring pericardial patch, coronary artery injury requiring intraoperative repair, postoperative hypotension, right ventricular outflow tract (rvot ) obstruction due to rotation of pulmonary valve requiring valve explant, bradycardia requiring permanent pacemaker implant, postoperative stroke, high pressure gradients (25.4 mmhg), and severe pulmonary regurgitation.Based on the available information medtronic product may have been associated with the adverse event(s).Among patients in the transcatheter group, adverse events included: endocarditis (melody median time 27.5 months post-implant), sternal pulmonary edema, rvot conduit rupture, valve embolization, hematoma, high pressure gradients (26.9 mmhg), and moderate pulmonary regurgitation.Based on the available information medtronic product may have been associated with the adverse event(s).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 II AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12701841
• MDR Text Key: 278554026
• Report Number: 2025587-2021-03164
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980043
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 26 YR
• Patient Weight: 67