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

Model Number HC15022

Device Problem Gradient Increase (1270)

Patient Problems Pulmonary Insufficiency (2022); Pulmonary Valve Stenosis (2024)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 3 years and 5 months post implant of this 22mm pulmonary bioprosthetic valved conduit, balloon valvuloplasty was performed due to moderate stenosis.Post valvuloplasty, pulmonary insufficiency was present.Then, 4 years and 2 months post implant of the pulmonary bioprosthetic valved conduit, cardiac magnetic resonance imaging (mri) revealed moderate stenosis redeveloped and elevated right ventricle (rv) pressures.It was reported the patient was symptomatic with increasing fatigue.Ultimately, 5 years post implant, an 18mm transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve.No additional adverse patient effects were reported. .

• Brand Name: HANCOCK
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9531860
• MDR Text Key: 173111291
• Report Number: 2025587-2019-03917
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HC15022
• Device Catalogue Number: HC15022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• 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: 20 YR
• Patient Weight: 53