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

Model Number T505C225

Device Problems Improper or Incorrect Procedure or Method (2017); Misassembly by Users (3133)

Patient Problem Not Applicable (3189)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

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 Description

Medtronic received information that this patient underwent a complex cardiac operation, involving an aortic root replacement (medtronic bioprosthetic valve inside of a non-medtronic tube graft), triple coronary artery bypass grafting (cabg), and the implantation of a temporary epicardial pacing wire.After the initial implant of the bioprosthetic valve, an intra-operative transesophageal echocardiogram (tee) demonstrated the valve was functioning as expected.The chest was closed and the patient was transferred from the operating room in stable condition.Approximately 35 minutes post-operative, the surgical team realized the valve holder of the bioprosthetic valve was not removed prior to closing the patient and remained attached to the valve.The patient was then transferred back to the operating room and underwent an additional procedure where the valve holder was successfully located and removed.An intra-operative transesophageal echocardiogram (tee) revealed the valve was functioning as expected.The patient was transferred from the operating room in stable condition.No additional adverse patient effects were reported.

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7868327
• MDR Text Key: 119949436
• Report Number: 2025587-2018-02402
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2018

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: 11/28/2021
• Device Model Number: T505C225
• Device Catalogue Number: T505C225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 09/12/2018
• Date Device Manufactured: 11/29/2016
• 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