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

Model Number ENVPRO-16-US

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Ischemia (1942); Perforation (2001); Blood Loss (2597)

Event Date 12/06/2018

Event Type  Death  

Manufacturer Narrative

Other relevant device(s) are: product id: e volutr-34-us, serial/lot #: (b)(4), ubd: 25-apr-2020, udi#: (b)(4).Product analysis: the products were not returned and discarded by the customer; therefore, no product analysis can be performed.  conclusion: without return of the products, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that this transcatheter bioprosthetic valve was attempted to be implanted in a previously implanted transcatheter bioprosthetic valve, that dislodged towards the coronary sinuses and resulted in severe paravalvular leak (pvl).The valve was loaded without issue and a good load was confirmed via fluoroscopy.During advancement of the delivery catheter system (dcs) with the second valve, the first valve dislodged toward the annulus.At this point it was decided to not implant the second valve.The physician suspected that implanting the second valve would likely result in coronary occlusion due to the proximity to the left main coronary artery.The first valve was attempted to be snared, but that was unsuccessful as the valve would not move.It was decided to deploy the second valve with support of a ventricular assist device or conversion to surgery, however the second valve was unable to be deployed due to dislodgement during deployment attempts with controlled pacing.Subsequently, the valve was recaptured and removed, and surgical intervention was performed.Four days after implant, the patient expired due to complications of mesenteric ischemia.Per the physician, the mesenteric ischemia was a result of open abdomen exposure during surgery.The reason for open abdominal surgery was a perforation of the right common iliac artery.It was unknown if the perforation was caused by the dcs.

Manufacturer Narrative

Additional information was received: the iliac perforation was noted after the surgical incision was made.One hour later, bleeding was noted in the retroperitoneal space.(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENVEO PRO 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: 8204116
• MDR Text Key: 131649221
• Report Number: 2025587-2018-03580
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00643169987210
• UDI-Public: 00643169987210
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• 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
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2020
• Device Model Number: ENVPRO-16-US
• Device Catalogue Number: ENVPRO-16-US
• Device Lot Number: 0009288911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2019
• Date Device Manufactured: 08/21/2018
• 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): Death
• Patient Age: 73 YR