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 Problems Stroke/CVA (1770); Embolus (1830); Headache (1880); Hemorrhage, Cerebral (1889)

Event Date 12/17/2013

Event Type  Injury  

Manufacturer Narrative

From the available information, a conclusive cause for the stroke nor the relationship to the device could not be determined.A supplemental report will be filed if additional information is received.

Event Description

Medtronic received information that 3 months post valve-in-valve procedure, the patient had an embolic stroke.Heparin was started and three days later, the patient reported symptoms of headache.Computed tomography (ct) revealed left occipital intra-cerebral hemorrhage (ich).The patient was started on isotonic fluids and kepra medication as a precaution and the anticoagulants were discontinued.The physician felt that the embolic stroke was related to the device.No further adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the product remains implanted, therefore, no product analysis can be performed.Conclusion: per the instructions for use (ifu), stroke is a potential procedural complication.With the reported information, the exact cause of the reported clinical observation cannot be confirmed.No allegations were made against the device, and there was no indication that a malfunction or misuse contributed to the reported event.(b)(4).

Manufacturer Narrative

Additional information was received.A good faith effort will be made to obtain the applicable information relevant to the report.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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3819223
• MDR Text Key: 11964254
• Report Number: 2025587-2014-00307
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2017

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: 10/14/2014
• 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: 05/21/2014
• Initial Date FDA Received: 05/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/29/2014; 02/07/2017
• Date Device Manufactured: 11/06/2013
• 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): Other; Required Intervention
• Patient Age: 00077 YR
• Patient Weight: 96