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

Model Number HC100-12

Device Problem Obstruction of Flow (2423)

Patient Problems Congestive Heart Failure (1783); Death (1802); Pulmonary Valve Stenosis (2024); Sepsis (2067); Respiratory Failure (2484); Multiple Organ Failure (3261)

Event Type  Injury  

Event Description

Medtronic received information that a journal article entitled ¿long-term results after correction of persistent truncus arteriosus in 83 patients¿, doi:10.1016/j.Ejcts.2009.12.022, analyzed long-term results after correction/repair of truncus arteriosus in one institution over a 28 year span.Of the 83 patients, repair with reconstruction of the right ventricular to pulmonary artery continuity was performed with a valved conduit in 80 patients, and other methods in the remaining three patients.Within the study time frame 27 deaths occurred, 19 of which were ¿early¿ (mean 4.1 days post-operative) with causes of heart failure (n=11), multiple organ failure (n=3), sepsis (n=2), pulmonary hypertensive crisis (n=2), and sudden death (n=1).The remaining eight deaths occurred ¿late¿ (median 68 days post-operative) with causes of heart failure (n=3), sepsis (n=2), respiratory failure (n=2), and other (n=1).Other non-death adverse events included: 41 re-operations for conduit dysfunction (with a mean of 5.8 years post-operative), 12 trunca l valve replacements, 11 balloon dilatation or stents for conduit obstruction, pulmonary branch stenosis, aortic arch obstruction, orvena cava stenosis.Thirteen medtronic products were implanted in the study population, including hancock bioprosthetic valved conduit (n=12) and contegra pulmonary valved conduit (n=1).None of the observations stated in the article were clearly associated with medtronic products.

Manufacturer Narrative

Based on the information available, no conclusion can be drawn with this report.None of the observations stated in the article were clearly associated with medtronic products.(b)(4).

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: 4246067
• MDR Text Key: 20976138
• Report Number: 2025587-2014-00889
• 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: HC100-12
• Device Catalogue Number: HC100-12
• 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): Required Intervention