MAUDE Adverse Event Report: LIVANOVA CANADA CORP PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVES

Model Number PVS25

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Rupture (2208)

Event Date 10/21/2019

Event Type  Death  

Manufacturer Narrative

Per perceval ifu, it is indicated that "the balloon can be inflated at the required pressure (4atm) for 30 seconds".For this reason, based on the case history reported the device code (b)(4) was chosen, along with (b)(4) (no other device issues were reported).Device discarded.

Event Description

On (b)(6) 2019, a patient received a percival pvs25 to replace the native aortic valve (congenital bicuspid).The sizing seemed appropriate.However, three days after the percival implant the patient experienced annular rupture involving the entire left coronary sinus.A re-do surgery was performed on the same day ((b)(6) 2019).The pvs25 was explanted, the rupture was fixed and a percival pvs21 was ultimately implanted.The patient is reportedly alive after the re-intervention.It is reported that, during the pvs25 implant, the ballooning was inflated to 4 atm for 40-45 sec.

Event Description

On (b)(6) 2019, a patient received a perceval pvs25 to replace the native aortic valve (congenital bicuspid).The sizing seemed appropriate.However, three days after the perceval implant the patient experienced annular rupture involving the entire left coronary sinus.A re-do surgery was performed on the same day ((b)(6) 2019).The pvs25 was explanted, the rupture was fixed and a perceval pvs21 was ultimately implanted.The patient is reportedly alive after the re-intervention.It is reported that, during the pvs25 implant, the ballooning was inflated to 4 atm for 40-45 sec.Additional information received from the site confirmed that the patient passed away after the second surgery (exact date not provided).

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1210, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1210) perceval heart valve at the time of manufacture and release.Since the device was discarded after the explant, no further investigation is possible at this time.Based on the information available, the root cause of the reported event cannot be definitively stated.However, based on the document review performed, no manufacturing deficiencies were identified.Should additional information become available, the manufacturer will re-assess the event and submit a follow-up report.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9339320
• MDR Text Key: 166979483
• Report Number: 3004478276-2019-00309
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)220519
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2020

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: 05/19/2022
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 12/12/2019; 01/21/2020
• Supplement Dates FDA Received: 01/09/2020; 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 68 YR