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

Model Number	HC15025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Hemothorax (1896); Pleural Effusion (2010)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the device remains implanted, therefore no product analysis can be performed.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 during the surgery to implant this 25mm pulmonary valved conduit, bleeding was noted on the suture lines.The patient was placed back on cardiopulmonary bypass (cpb) and the suture lines were reinforced.After removal from cpb, bleeding was present again.Cpb was re-initiated and the areas were reinforced with more sutures.Then, the patient weaned from cpb without difficulty and without significant residual bleeding.At the conclusion of the procedure, atrial fibrillation (afib) and atrial flutter were present.The patient was successfully cardioverted and sent to the intensive care unit (icu) in stable condition.In the immediate post operative period the patient developed "brisk, sanguineous" output from the mediastinal and pleural drains.The patient was hypotensive.Atrial flutter occurred again, and the patient was unable to be paced with the temporary pacing wires,but spontaneously corrected to normal sinus rhythm.A second atrial flutter episode was successfully treated with external pacing.A third arrhythmia episode however required 1 minute of cardiopulmonary resuscitation (cpr), epinephrine and defibrillation.At that time the patient's chest was re-opened and the temporary pacing wires were repositioned.No active bleeding was noted, and the chest was irrigated.The patient's chest was left open.The patient remained clinically stable, and two days later, the patient's chest was successfully closed.Approximately two weeks post conduit implant, persistent left pleural effusions and a retained hemothorax were present.A thoracoscopy was performed to evacuate the hemothorax.In total, approximately 2 l of "old blood" and pleural debris were removed.The patient tolerated the procedure well with clinical improvement.He was discharged 7 days later with no additional adverse patient effects.

• 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: 11351371
• Report Number: 2025587-2021-00616
• Device Sequence Number: 4830779
• Product Code: LWR
• UDI-Device Identifier: 00643169646612
• UDI-Public: 00643169646612
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P790007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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: 10/19/2022
• Device Model Number: HC15025
• Device Catalogue Number: HC15025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/19/2021
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 41