MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION COREVALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number MCS-P3-943

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bradycardia (1751)

Event Date 10/04/2013

Event Type  Injury  

Manufacturer Narrative

Conduction disturbances are a potential procedural complication per the corevalve ifu and are associated with any cardiac or thoracic procedure, open or catheter-based, and can be resolved with medical treatment or the implant of a permanent pacemaker.Bradycardia is generally a result of known potential adverse effects per corevalve ifu, such as conduction disturbances or hypertension, or an effect of certain medications or other pre-existing patient conditions and can be resolved with medical treatment or the implant of a permanent pacemaker.The device remains implanted.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information that following the implant of this transcatheter bioprosthetic valve, junctional bradycardia was noted.Two days post-implant, new left bundle branch block (lbbb) was noted.No treatment provided.Four months post-implant the patient was admitted to the hospital for symptomatic bradycardia, resolved by the implantation of a permanent pacemaker.No other adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: COREVALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3806122
• MDR Text Key: 21155942
• Report Number: 2025587-2014-00281
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2014
• Device Model Number: MCS-P3-943
• Device Catalogue Number: MCS-P3-943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/12/2014
• Supplement Dates Manufacturer Received: 04/17/2014
• Supplement Dates FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2013
• 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: 00078 YR