MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR SANTA ROSA TALENT AORTIC CUFF XCELERANT - HYDRO (US); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number AXF2828W29XH

Device Problems Burst Container or Vessel (1074); Fracture (1260)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348); Blood Loss (2597)

Event Date 05/01/2012

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: ixw1414c80xh, serial/lot #: (b)(4), ubd: (b)(6) 2011, udi#: (b)(4); product id: iw1416c105xh, serial/lot #: (b)(4), ubd: (b)(6) 2012, udi#: (b)(4); product id: af2814c140xh, serial/lot #: (b)(4), ubd: (b)(6) 2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

A talent stent graft system was implanted in the patient for an unknown endovascular treatment on (b)(6) 2010.It is reported that a stent graft fracture occurred approximately 2 years post implant.It was reported that the stent graft had come apart and that the patient had some bleeding.The patient reported that intervention was carried out to resolve the event.No additional clinical sequelae were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: TALENT AORTIC CUFF XCELERANT - HYDRO (US)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7676796
• MDR Text Key: 113621943
• Report Number: 2953200-2018-00998
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2010
• Device Model Number: AXF2828W29XH
• Device Catalogue Number: AXF2828W29XH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2018
• Date Device Manufactured: 09/09/2008
• 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: 70 YR
• Patient Weight: 76