MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO R DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number ENVEOR-L

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Embolism (1829); Septic Shock (2068); Peritonitis (2252); Bowel Perforation (2668)

Event Date 05/27/2020

Event Type  Death  

Manufacturer Narrative

Citation: kadoya y et al.Multiple small bowel perforations associated with cholesterol crystal embolization after transcatheter aortic valve replacement.Jacc cardiovasc interv.2020 aug 10;13(15):1831-1832.Doi: 10.1016/j.Jcin.2020.04.030.Epub 2020 may 27.Earliest date of publish used for date of event and date of death.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature case report regarding an (b)(6)-year-old female patient with a history of peripheral artery disease and advanced chronic kidney disease who presented with decompensated heart failure associated with severe aortic stenosis.Computed tomography (ct) revealed an extremely atherosclerotic, twisted descending aorta with an abdominal aortic aneurysm measuring 43 mm.Due to the patient¿s advanced age, comorbidities, and anatomic difficulties for alternative access, the physician/author decided to perform transfemoral transcatheter aortic valve replacement (tavr).A 26 mm medtronic evolut r (serial number not provided) was implanted and successfully mitigated the patient¿s heart failure.Twelve days after tavr, the patient developed fever and severe abdominal pain.Physical examination showed no livedo reticularis or blue toe syndrome.Laboratory results found no eosinophilia or acute deterioration in renal function.Ct identified free air in the abdominal cavity and fluid around the small bowel.A small bowel perforation with generalized peritonitis was diagnosed and emergency surgery was performed.During the surgery, multiple ileal ulcerations and perforations were detected, and the small bowel was partially resected.The histological examination of the resected ileum exhibited multiple needle-shaped clefts in the arteries, which confirmed cholesterol crystal embolization.Despite intensive care, the patient developed reperforation and septic shock, and died due to multiple organ failure 46 days after tavr.No additional adverse patient effects or product performance issues were reported.

• Brand Name: ENVEO R DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10542200
• MDR Text Key: 207205729
• Report Number: 2025587-2020-02842
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ENVEOR-L
• Device Catalogue Number: ENVEOR-L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2020
• 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): Death
• Patient Age: 86 YR