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

Model Number HC15022

Device Problems Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problem Pulmonary Insufficiency (2022)

Event Date 03/11/2020

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 9 years and 6 months post implant of this 22mm pulmonary valved conduit in a (b)(6)-year-old pediatric patient, there was mild pulmonary insufficiency, however the leaflets were functioning appropriately.The 22mm conduit was measured to be 19mm with a subvalvar obstruction which was thought to be a muscle bundle.The physician thought that since there was a complex lesion, distal to the conduit, primary intervention was necessary, and several balloon dilations of the lpa were performed, which relieved the gradient, however after 8 hours of complex intervention, the decision was made to delay conduit intervention since the gradient decreased to around 25mmhg, and the conduit remains implanted.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: 9916784
• MDR Text Key: 188389724
• Report Number: 2025587-2020-01088
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490908818
• UDI-Public: 00681490908818
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2015
• Device Model Number: HC15022
• Device Catalogue Number: HC15022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2020
• Date Device Manufactured: 03/10/2010
• 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: 19 YR
• Patient Weight: 64