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

Model Number UNKNOWN

Device Problem Calcified (1077)

Patient Problems Congestive Heart Failure (1783); Pulmonary Regurgitation (2023); Vascular System (Circulation), Impaired (2572)

Event Date 04/01/2010

Event Type  Injury  

Event Description

Additional information stated the conduit was implanted for 11 years before the intervention took place, and the patient was (b)(6) at and weighed (b)(6) the time of the intervention.

Event Description

Medtronic received information that a young female patient (age and weight not reported) with down¿s syndrome was successfully implanted with a medtronic 24 mm pulmonary conduit (model/serial not reported).Post-implant (time from implant not reported), the patient had progressive conduit dysfunction with stenosis and moderate pulmonary regurgitation associated with right heart failure.A magnetic resonance imaging (mri) confirmed conduit degeneration with a decreased blood flow of 32% to the right lung and 68% to the left lung.During a surgical procedure, an angiogram revealed a calcified and narrowed conduit.Right pulmonary artery stenosis was treated with a 36 mm stent, delivered by catheter and expanded by balloon, followed by successful implantation of a medtronic transcatheter pulmonary valve.Post-operative testing showed stable hemodynamics with no pulmonary regurgitation and excellent valve position.At six month follow-up the patient¿s condition was good with improved lifestyle changes.No additional adverse patient effects were reported.

Manufacturer Narrative

The device was not returned to medtronic.(b)(4).Title: medtronic melody transcatheter pulmonary valve.Improving the quality of life authors: hill, s.L., chisolm, j.L., cheatham, j.P.Citation: congenital cardiology today, 2010, 8(4):1-5 the date of publish was used for the event date.

Manufacturer Narrative

Conclusion: no devices were returned, and no unique device identifier numbers were provided.Without this information a review of the device history record could not be performed and root cause could not be identified.

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: 4809893
• MDR Text Key: 5925959
• Report Number: 2025587-2015-00614
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,health professional,lit
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2015
• 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
• Patient Age: 00033 YR
• Patient Weight: 55