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

Model Number PVS21

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

The returned valve prosthesis was received in generally good condition.

Event Description

A perceval valve size 21 mm was implanted following standard protocol.After aortotomy closure, tee showed the valve had migrated into the sinus of valsalva, the patient was then placed back on bypass.The valve was removed, inspected, and then re-implanted.After coming off bypass a second time, tee again showed that the valve had migrated into the sinus of valsalva.The patient again placed on bypass and the valve was explanted.A crown tissue valve was then implanted to avoid further delay.The crown was sized to a 21 mm valve, which was implanted successfully.

Manufacturer Narrative

The visual inspection performed on the returned prosthesis confirmed the absence of manufacturing defects.Dimensional analysis confirmed the absence of dimensional irregularity.Hydrodynamic testing conducted on the returned prosthesis showed confirmed that the valve functionality was normal.No displacement of the valve was detected during pulsatile flow testing, and it was not possible to replicate the reported anomaly described in the initial case history.The manufacturing and material records for the perceval heart valve, model #icv1208 , s/n # (b)(4) and nitinol stent, as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.Based on the performed analysis, the reported issue cannot be explained by any factor intrinsic in the involved device.

Event Description

(additional information): the physician stated that he probably didn¿t account for a ridge of calcium that was smooth, which probably accounted for the valve not seating properly; therefore, once the aorta was closed an pressurized the valve migrated up.

Manufacturer Narrative

Based on the event information provided, the event can reasonably be attributed to the presence of excess calcium in the annulus.The perceval instructions for use state that "eccentric/bulky protruding intra-luminal calcifications must be removed".As such, the event is considered to be the result of a failure to follow the instructions in the ifu.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• MDR Report Key: 7426265
• MDR Text Key: 105318190
• Report Number: 3004478276-2018-00172
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)200831
• 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: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2020
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention