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

Model Number VAMC4242C200TU

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

Patient Problems Anemia (1706); Fever (1858); Hemorrhage/Bleeding (1888); Rash (2033); Swelling (2091); Electrolyte Imbalance (2196); Constipation (3274)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: v amc4242c200tu, serial/lot #: (b)(4), ubd: 27-may-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant stent graft system was implanted in the patient for the endovascular treatment of a fusiform descending thoracic aneurysm.It was noted a non-mdt stent graft (gelweave) was previously implanted in the ascending aorta approximately 2 months previously.It was reported from one post the index procedure to approximately 2 weeks post the index procedure the patient experienced the following symptoms: thrombocytopenia resolving without treatment abdominal pain unresolved without treatment elevated liver enzymes recovering without treatment.Anemia with drop in hb unresolved and continuing with treatment hypokalemia resolved with treatment constipation resolved with treatment maculopapular rash by right neck area related to surgical tape dressing used for central line access resolved with treatment.Postoperative fever with symptoms of hypovolemic hyponatremia, lactic acidosis¿ related to the post implantation syndrome.This was successfully treated and confirmed as resolved.Occult gastrointestinal bleeding treated however unresolved and continuing with treatment left arm swelling with mild edema around the incision site (procedure access) resolved with treatment.All of the reported events were assessed as related to the index procedure.No additional clinical sequelae were reported and the patient will be monitored.

Manufacturer Narrative

Additional information received: the valiant captivia stent grafts implanted during the index procedure were placed in zones 3, 4 and 5.The previously reported abdominal pain was reported as likely due to the anesthesia and acute surgery.A ct was carried out 3 months post the index procedure showed no blood loss.The patient recovered without treatment.The previously reported anemia was treated with medication but is still unresolved.All previously reported events were assessed as related to the index procedure by both the investigator and the sponsor.The patient also experienced hypomagnesemia 3 months post the index procedure which was assessed as related to the study procedure by the investigator and the sponsor, and recovered without treatment.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: VALIANT CAPTIVIA - CW
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 8119301
• MDR Text Key: 128869718
• Report Number: 2953200-2018-01643
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169346734
• UDI-Public: 00643169346734
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2019

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 Expiration Date: 02/28/2020
• Device Model Number: VAMC4242C200TU
• Device Catalogue Number: VAMC4242C200TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2018
• Initial Date FDA Received: 11/30/2018
• Supplement Dates Manufacturer Received: 12/13/2018; 02/20/2019
• Supplement Dates FDA Received: 01/07/2019; 03/11/2019
• Date Device Manufactured: 02/28/2018
• 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: 61 YR
• Patient Weight: 52