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

Model Number T505

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

Patient Problem Hematoma (1884)

Event Date 07/08/2002

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen was disposed of by the medical institution.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information that approximately one year post implant of this bioprosthetic valve, it was explanted and replaced due to a large blood clot.No further adverse patient effects were reported.

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: 5408088
• MDR Text Key: 37418880
• Report Number: 2025587-2016-00126
• 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: company representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/03/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T50525H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 02/03/2016
• Supplement Dates Manufacturer Received: 09/03/2014
• Supplement Dates FDA Received: 09/19/2017
• 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): Required Intervention
• Patient Age: 00079 YR