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

Model Number	HC105-20
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Codes	Corneal Pannus (1447); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)
Date of Event	08/21/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, approximately 3.5 cm of the valve was returned with a transcatheter valve inside of the valve.Pannus fused the devices together.Due to the return condition of the product, the leaflets and commissures could not be assessed.Conclusion: medtronic is unable to determine a relationship between the product and the reported clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that four years and two months post implant of this bioprosthetic valve in a seven year old pediatric patient, a transcatheter pulmonary bioprosthetic valve was implanted valve-in-valve due to a gradient measurement of 90mmhg, regurgitation and stenosis.Prior to replacement, an echocardiogram (ecg) was performed that revealed the gradient measurement while the patient was exercising.No additional adverse patient effects were reported.

• Brand Name: HANCOCK
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7476439
• Report Number: 2025587-2018-01039
• Device Sequence Number: 16514425
• Product Code: LWR
• UDI-Device Identifier: 00681490908597
• UDI-Public: 00681490908597
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P870078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2014
• Device Model Number: HC105-20
• Device Catalogue Number: HC105-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 YR
• Patient Weight: 30