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

Model Number HC150-12

Device Problems Obstruction of Flow (2423); Material Integrity Problem (2978)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 02/21/2014

Event Type  Injury  

Event Description

Medtronic received information that a 12 millimeter version of a bioprosthetic valved conduit had been used in a rastelli procedure to restore continuity between the right ventricle and pulmonary artery following palliative shunting.The device, implanted at another facility, was explanted following development of a right ventricular outflow tract (rvot) obstruction.A catheterization performed after the rvot obstruction observation also noted right pulmonary artery stenosis that was treated with stenting, and the patient was referred for replacement of this conduit.During the reoperation, it was observed that there was a significant fibro-intimal peel within this conduit.The device was replaced with an 18 mm medtronic pulmonary valved conduit.

Manufacturer Narrative

To date, the device has not been returned for analysis.Also, the serial number remains unknown, so a device history record review could not be performed.Based on submitted photographs, it could not be confirmed if there were any quality issues with the device.In general, the reported information indicates multiple complications above and beyond what may have been device-related.No root cause could be determined from the photographs and information provided.A supplemental report will be filed if the device is returned for analysis or if additional information is received.

Manufacturer Narrative

This event was reported in conjunction with a report of the replacement of the 18 mm pulmonary valved conduit; a separate report has been filed on that device.This device¿s serial number and device disposition were not reported; additional information has been requested.A review of medtronic¿s database did not show any previous reports or returned devices that were associated with this reported issue.A supplemental report will be filed when the investigation is completed or if additional information is obtained.(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): 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: 4139853
• MDR Text Key: 4934653
• Report Number: 2025587-2014-00731
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: HC150-12
• Device Catalogue Number: HC150-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 10/03/2014
• Supplement Dates Manufacturer Received: Not provided; 10/17/2014
• Supplement Dates FDA Received: 10/28/2014; 09/15/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 00002 YR
• Patient Weight: 12