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

Model Number T10012

Device Problem Gradient Increase (1270)

Patient Problems Death (1802); Insufficiency, Valvular (1926); Left Ventricular Failure (1948); Pneumonia (2011)

Event Date 09/14/2008

Event Type  Death  

Event Description

Medtronic received information via a journal article in the european journal of cardio-thoracic surgery regarding a retrospective study of 32 patients who underwent common arterial trunk repair with right ventricular outflow tract (rvot) reconstruction between january 2000 and december 2006.There were 16 male patients and 16 female patients, with a mean age of 74 days (44% were less than 30 days old).The mean weight at operation was 3.6kg (50% weighed less than 3kg).Fifteen (15) of the 32 patients received an extracardiac conduit (heterograft or homograft) to establish right ventricle-to-pulmonary artery continuity.A homograft was used in 1 patient; the remaining 14 patients received the hancock porcine valve housed in a dacron tube conduit (1 patient), a non-medtronic porcine valve with pericardial conduit (1 patient), and the contegra bovine jugular vein conduit (12 patients).The diameters ranged from 11 to 15 mm.Early postoperative data (within 30 days) of these 15 patients: two (2) deaths due to lung infection and neurological damage.Mean right ventricle to pulmonary artery gradient (rv-pa) of 15 mmhg.Mean ratio of right ventricular pressure to left ventricular pressure (rv/lv) of 0.48.Moderate-to-severe truncal valve regurgitation in 2 patients.Moderate pulmonary regurgitation in 1 patient late results (mean duration of follow-up of 40 months) of the remaining 13 patients: three (3) deaths due to pneumonia 3-7 months postoperatively.These patients had satisfactory echocardiographic examination prior to death, with moderate truncal valve regurgitation.The author warned that the relationship between the quality of the rvot reconstruction and the "so-called pneumonia" could not be excluded completely; the deaths may have been a combination of lung infection, truncal valve regurgitation, and lv-impaired function.No problem was noted with the rvot reconstruction.Five (5) patients underwent rvot re-operations after a mean delay of 22.5 months.Three (3) of these patients had replacement of the conduit with a bovine jugular conduit, and two (2) patients had reconstruction of the rvot with a ptfe monocusp valve.The reason for re-operation was not reported.Mean right ventricle to pulmonary artery gradient (rv-pa) of 83 mmhg (significantly higher in this group of patients than the non-conduit patients).Mean rv/lv pressure of 1.02.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: HANCOCK
• 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: 4246401
• MDR Text Key: 4989211
• Report Number: 2025587-2014-00892
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2014

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: T10012
• Device Catalogue Number: T10012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 11/12/2014
• Supplement Dates Manufacturer Received: 10/17/2014
• Supplement Dates FDA Received: 09/15/2017
• 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): Death; Required Intervention