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); Obstruction of Flow (2423)

Patient Problems Aortic Regurgitation (1716); Endocarditis (1834); Mitral Regurgitation (1964); Stenosis (2263); Thromboembolism (2654)

Event Date 07/29/1994

Event Type  Injury  

Manufacturer Narrative

Citation: bortolotti u et al.Porcine valve durability: a comparison between hancock standard and hancock ii bioprostheses.Ann thorac surg.1995 aug;60(2 suppl):s216-20.Doi: 10.1016/0003-4975(95)00255-j.Presented at the vi international symposium for cardiac bioprostheses, vancouver, bc, canada, july 29¿31, 1994.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 the return of the product, no definitive conclusion can be made regarding the clinical observations.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a comparison of the durability of the hancock standard bioprosthesis and the hancock ii bioprosthesis.All data were collected from a single center between 1970 and 1992.The overall study population included 954 patients (predominantly male; mean age 55 years), 769 were implanted with medtronic hancock standard bioprosthetic valves (196 aortic position; 502 mitral position; 71 mitral and aortic position).No serial numbers were provided.Among all hancock standard patients, approximately 8 deaths were reported to be valve-related.No other details were provided.Based on the available information, medtronic product may have been associated with the deaths.Among all hancock standard patients, adverse events included: reoperation, structural valve deterioration (tissue calcification, cusp stiffening, valve stenosis, valve incompetence, and commissural disruption), endocarditis (time interval from valve implant to onset of endocarditis was not reported), and thromboembolism.Based on the available information, medtronic product may have been associated with the adverse events.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: 9087466
• MDR Text Key: 163363993
• Report Number: 2025587-2019-02865
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• 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
• Date Manufacturer Received: 09/11/2019
• 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): Required Intervention
• Patient Age: 55 YR