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

Model Number HC15016

Device Problems Break (1069); Calcified (1077); Crack (1135); Hole In Material (1293); Occlusion Within Device (1423); Torn Material (3024)

Patient Problem Insufficiency, Valvular (1926)

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 25 patients with extra-cardiac conduit valve repair surgeries between the right ventricle and pulmonary arteries to treat various congenital cardiac diseases.16 of the 25 devices were medtronic bioprosthetic valved conduits; the remaining nine were devices from two other manufacturers.The primary observations for the entire children¿s population was that device dysfunction was mainly related to stenotic lesions due to fusion or adhesion of the device¿s commissures and/or calcification of the device cusps.The article reported that 12 medtronic devices were explanted.A graphic in the article showed the following five types of device issues specific to explanted medtronic devices from the combined adult mitral device and children conduit populations (but did not specify how many of each of the occurrences were for the 12 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.The freedom from reoperation for the children population ranged from 92.9% at five years to 8.5% at nine years, and 0% at 9 years and 3 months (the longest time of implant of the children population at the time of the article).The average age of the 25 patients in this report was six years old with an average of age 5.2 for patients with medtronic devices in this population.Their devices were implanted from (b)(6) to (b)(6), with an average follow-up period of (b)(6).The conduit valve sizes ranged from 12 mm to 25 mm.There were no deaths or post-operative complications reported for the 12 patients whose devices were explanted and replaced.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 and device malfunctions observed from the adult 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).

Manufacturer Narrative

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

• Brand Name: HANCOCK MODIFIED ORIFICE VALVED CONDUIT
• 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: 4271853
• MDR Text Key: 5003559
• Report Number: 2025587-2014-00922
• 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: HC15016
• Device Catalogue Number: HC15016
• 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