MAUDE Adverse Event Report: HEART VALVES SANTA ANA HANCOCK; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number HC15022

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endocarditis (1834); Fever (1858)

Event Date 06/19/2014

Event Type  Injury  

Event Description

Medtronic received information that three days post implant of this bioprosthetic valve, the patient presented with a high fever.Blood cultures were negative for sepsis indicators.A transesophageal echocardiogram (tee) showed no regurgitation and good valve he modynamics.The patient was treated medically for endocarditis.No other adverse patient effects were reported.

Manufacturer Narrative

Attempts to verify the date of event and implant date have been unsuccessful; the dates presented here are approximations.The device remains implanted.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Multiple attempts to obtain additional details regarding this event have been unsuccessful.A supplemental report will be filed if additional details are received.

Manufacturer Narrative

Additional information was received regarding the date of this event and the implant date of the device.

Manufacturer Narrative

Medtronic received additional information that the transesophageal echocardiogram (tee) performed three days post implant showed mild regurgitation.The initial information received stated there was no regurgitation.(b)(4).

Manufacturer Narrative

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

• Brand Name: HANCOCK
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 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: 4623965
• MDR Text Key: 5587880
• Report Number: 2025587-2015-00349
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: P790007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2017
• Device Model Number: HC15022
• Device Catalogue Number: HC15022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2013
• 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