MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995

Device Problems Hole In Material (1293); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 12/01/2006

Event Type  Injury  

Event Description

Medtronic received information from a journal article that a patient implanted with an aortic root bioprosthesis experienced a post-implant spontaneous perforation of the device¿s valsalva sinus.It was reported that that this device was implanted as a replacement to another device of the same model and size.One year after this device¿s implant, a false aneurysm was noted and the patient underwent a surgical replacement.It was observed that there were 20 mm diameter holes in the device¿s left and non-coronary sinuses.Another manufacturer¿s device was implanted with no subsequent adverse patient effects.The article noted that these patients were part of a population who had their devices implanted between (b)(6) 1999 and (b)(6) 2002; the date of this complaint was not indicated in the article.A separate report has been filed on the patient¿s first replacement device.

Manufacturer Narrative

A review of the maude database entries for this model family did not show a report had previously been submitted for this journal article or individual complaint.A review of medtronic¿s databases did not find a previously existing record for this article or individual complaint.(b)(4) perforation of the valsalva sinus after implantation of medtronic freestyle aortic bioprosthesis nobuchika ozaki, md; yutaka hino, md; yuji hanafusa, md; teruo yamashita, md; kenji okada, md; takuro tsukube, md; and yutaka okita, md kobe university graduate school of medicine, division of cardiovascular, thoracic, and pediatric surgery, kobe, japan the annals of thoracic surgery, volume 82, issue 6, december 2006, pages 2282¿2285.Doi:10.1016/j.Athoracsur.2006.04.074.

Manufacturer Narrative

A device history record review could not be performed as the serial number was not provided.Based on the limited information received, a root cause of the adverse event could not be determined.

Manufacturer Narrative

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

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• 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: 4238752
• MDR Text Key: 5014234
• Report Number: 2025587-2014-00862
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995J25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 00063 YR