MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number	VAMF2222C100TU
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captivia stent graft system was implanted during an endovascular procedure for and aortic intramural hematoma (imh).It was reported during the index procedure the patient had emergent total arch replacement.Physician requested that the rep bring in a 20x20 graft  the rep informed the physician that there was a 22x22.The rep brought in a 22x22, a24x24 and a26x26 graft to the case.After getting a measurement of 24mm the rep suggested a 24 or 26.The physician stated a 22  would be used because the implanted graft was small so a 22mm valiant was delivered to the field.The rep noted there was no imaging or ivus ultra sound available and the physician stated there was direct visualisation.The graft was deployed with out the reps visualisation and after deployment both physicians stated that the graft looked good.  it was reported during a ct one day post index procedure that the graft had migrated to the distal segment of the thoracic aorta.The patient was brought to the or where a thoracotomy was carried out and the 22x22x100 graft was explanted.It was then reported the patient expired two days later.No cause has been reported.  no additional clinical sequalae was provided and the patient has expired.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12735267
• Report Number: 9612164-2021-04159
• Device Sequence Number: 19865168
• Product Code: MIH
• UDI-Device Identifier: 00643169347120
• UDI-Public: 00643169347120
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2023
• Device Model Number: VAMF2222C100TU
• Device Catalogue Number: VAMF2222C100TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 84 YR