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

Model Number HC100-18

Device Problems Calcified (1077); Structural Problem (2506); Material Deformation (2976)

Patient Problems Corneal Pannus (1447); Death (1802); No Information (3190)

Event Date 07/01/2013

Event Type  Death  

Event Description

Medtronic received information via a literature review article regarding the use of new devices in congenital heart defect repair surgery that reoperation associated with failed valved conduits was associated with a mortality rate of 1%-3% at the time of the review.The mortality rate was reported for all similar products examined in the literature, which included models from this family of devices.The article noted that the limitations for this type of device included no growth potential, early calcification, structural degeneration, pannus formation, and excessive stiffness with anatomic compression/distortion.The article also reported that reoperation rates ranged from 19% at five years and 68% at 10 years, to 95%-100% at 15 years, depending on the device diameter, patient age at surgery and type of heart defect.The article was based on a review of published literature and did not include details regarding the number or dates of device implants or deaths, or patient demographics, and did not specifically associate the deaths with device limitations.

Manufacturer Narrative

With no device- or patient-identifying information, medtronic¿s complaint database could not be searched to identify any previously reported complaints that may have been included in this article.The reported date of death is an arbitrary value entered to facilitate electronic submission of this report.(b)(4).New technologies for surgery of the congenital cardiac defect authors: david kalfa, m.D., ph.D.And emile bacha, m.D.Rambam maimonides medical journal july 2013 - volume 4 - issue 3 - e0019.

Manufacturer Narrative

Death, calcification and pannus are known potential adverse events for this device.As the devices either were not returned for evaluation or identified to determine if a device had previously been returned for analysis, a failure mechanism was not able to be determined.

Manufacturer Narrative

Corrected information: no eval explain code.

• Brand Name: HANCOCK
• 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 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: 4211508
• MDR Text Key: 4980235
• Report Number: 2025587-2014-00815
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,health professional,lit
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HC100-18
• Device Catalogue Number: HC100-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Death; Hospitalization; Required Intervention