MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK MODIFIED ORIFICE BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 250

Device Problems Calcified (1077); Crack (1135); Hole In Material (1293); Structural Problem (2506); Torn Material (3024)

Patient Problems Endocarditis (1834); Insufficiency, Valvular (1926); Thromboembolism (2654)

Event Date 03/01/1995

Event Type  Injury  

Event Description

Medtronic received information from a 1995 journal article that compared the long term results of a typical valve replacement and the biological valves used for extra-cardiac conduit valves from a single facility in (b)(6).The article compared two sets of populations: adults who underwent a typical bioprosthetic heart valve replacement and children who had a conduit valve device implanted to treat congenital cardiac diseases.The article discussed 41 patients with bioprosthetic valve replacement surgeries that involved 44 devices.33 of the devices were hancock bioprosthetic heart valves manufactured by medtronic; the remaining 11 were another manufacturer¿s product.Of the 33 medtronic devices, 29 were implanted in the mitral valve position, two in the aortic valve position, and two in the tricuspid valve position.The sizes of the biological valves used ranged from 19 mm to 35 mm.The article noted that replacements of both manufacturers¿ devices in the adult population tended to have more regurgitant lesions caused by cracks or perforations in the heart valve cusps, and that these devices with malfunctions often exhibited regurgitation due to tears and/or perforations of the valves.Six of the patients with a medtronic device underwent explant due to a malfunction.A graphic in the article showed the following five types of device issues specific to explanted medtronic devices from a combination of the adult mitral device and children conduit populations (but did not specify how many of each of the occurrences were for the six devices in this report): adhesion of the commissural region, calcification, mobility loss, cusp atrophy, and cuspal cracks/perforations.Associated observations of regurgitation associated with the device issues ranged from none to severe regurgitation.Although the article did not present information on individual devices, it did indicate freedom of reoperation rates for the hancock devices implanted in the adult population ranging from 96% at five years of implant to 74% at 10 years and 10 months (the longest time of implant of the adult population at the time of the article).The average age of the adult patients in this report was (b)(6) years old.The 41 device implant procedures were performed between (b)(6) 1977 and (b)(6) 1980.The follow-up period average was 7.4 years.Of the seven re-operative cases from the adult population, one was performed with the primary observed complications of thromboembolism and infective endocarditis.The article did not specify which of the two manufacturers¿ devices was implanted.Without device-specific information available in the article, the device model reported here represents the most likely model that was available for implant at the time.Separate reports have been filed on a reported re-operative death from the adult population and the device malfunctions observed from the children population.

Manufacturer Narrative

Following a search of the fda maude database and medtronic¿s databases, it appears the issues included in this article were not previously reported either as individual or journal article complaints.Without device- or patient-identifying information, it could not be determined if any of the explanted devices had been returned to medtronic for analysis.(b)(4).Long term results for typical valve replacement and the biological valves used for extracardiac conduits valves authors: shuichi matsuno, yoshio yokota, fumitaka ando, fumio okamoto, shogo nakayama, tadashi ikeda, shigehiro otani.Department of cardiovascular surgery of the cardiac center at amagasaki hospital in hyogo prefecture journal of japan surgical society, volume 96 issue 3 publication date: march 1, 1995.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
• 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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4271851
• MDR Text Key: 15345653
• Report Number: 2025587-2014-00920
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P790007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 250
• Device Catalogue Number: 250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Age: 00043 YR