MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number	200H14
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Neurological Deficit/Dysfunction (1982)
Date of Event	10/06/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 200h14, serial/lot #: (b)(4), ubd: 22-jan-2021, udi#: (b)(4).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 or Problem Description
Medtronic received information that two days post implant of this bioprosthetic pulmonary valved conduit, the patient became hypotensive.The patient experienced cardiac arrest, and resuscitation measures were performed.The patient was placed on venous-arterial extracorporeal membrane oxygenation (ecmo), and underwent mediastinal exploration due to bleeding.Bleeding from the superior and inferior vena cava was noted.This was reported to be a result of sutures that tore through the surrounding tissue during the resuscitation measures.The vessel damage was repaired with sutures, and the patient was returned to the intensive care unit in critical but stable condition.There was no allegation that the contegra conduit or its function contributed to the cardiac arrest.Six days post implant of the conduit, cardiac catherization showed conduit thrombosis.Seven days post implant it was explanted and replaced with another conduit of the same size and model.It was reported that the conduit was "completely thrombosed".Thrombus was also removed from the right ventricle and main pulmonary artery.The patient remained on ecmo support after completion of the conduit replacement.Two days after conduit replacement, ecmo support was discontinued.Twelve days after the discontinuation of ecmo, the patient was removed from life sustaining therapies due to profound hypoxic neurological injury.It was reported that the neurological injury was a result of the cardiac arrest 21 days earlier.There was no evidence to suggest that the conduits or their function contributed to cardiac arrest or the patient's ultimate death.No autopsy was performed.

• Brand Name: CONTEGRA
• Common Device Name: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9426144
• Report Number: 2025587-2019-03684
• Device Sequence Number: 11322062
• Product Code: MWH
• UDI-Device Identifier: 00643169616905
• UDI-Public: 00643169616905
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2021
• Device Model Number: 200H14
• Device Catalogue Number: 200H14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/06/2019
• 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: Death; Required Intervention
• Patient Age: 5 YR