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

Model Number	HC15020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pulmonary Valve Stenosis (2024); No Information (3190)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: product id: hc15020, serial/lot #: (b)(4), ubd: 19-oct-2019, udi#: (b)(4).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 or Problem Description
Medtronic received information that 2 years 11 months this 20mm pulmonary valved conduit ((b)(4)) was being replaced for unknown reasons.Another 20mm pulmonary valved conduit ((b)(4)) was attempted and not used during the same replacement procedure for unknown reasons.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received additional information that 2 years 11 months this 20mm pulmonary valved conduit ((b)(4)) was replaced due to stenosis.Upon explant it was noted that the valve had very thickened dysplastic, essentially "frozen leaflets".The replacement 20mm valve ((b)(4)) the physician stated that prior to suturing it was noted the patient had an inflammatory reaction to the dacron of the conduit, so another medtronic conduit was used in its place without issue.There is no allegation against this valve.No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8126566
• Report Number: 2025587-2018-03283
• Device Sequence Number: 11195561
• Product Code: LWR
• UDI-Device Identifier: 00643169646599
• UDI-Public: 00643169646599
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P790007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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: 03/26/2022
• Device Model Number: HC15020
• Device Catalogue Number: HC15020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/14/2018
• 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: 5 YR
• Patient Weight: 21