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

Model Number 305_MOSAIC

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Vascular System (Circulation), Impaired (2572)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Citation: sanghvi k, ostial left main occlusion following surgical aortic valve replacement (savr) j card surg.(b)(6) 2018.Doi: 10.1111/jocs.13551.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a (b)(6) female with medical history of bicuspid aortic valve and severe aortic stenosis who underwent a surgical aortic valve replacement with a 19-mm medtronic mosaic bioprosthesis (serial number not provided).Post-implant, total occlusion of left main coronary artery (lmca) and hypotension was reported.The lmca was stented with non-medtronic bare metal renal stent.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES 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: 7359556
• MDR Text Key: 103103322
• Report Number: 2025587-2018-00651
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305_MOSAIC
• Device Catalogue Number: 305_MOSAIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR