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

Model Number PVS23

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems High Blood Pressure/ Hypertension (1908); Stenosis (2263)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

The device was received on mar 30, 2017.Gross examination was completed.The returned prosthesis was received blood stained.The visual inspections was performed on the returned prosthesis and confirmed the absence of manufacturing defects.

Event Description

After implanting perceval m, the valve was not symmetric and was not perfectly situated in the annulus.In this moment of the operation it was not clear if the problem was caused by the anatomy of the patient or of a dysfunction of the device.To be careful it was decided to take the valve out and use a stented valve with the same size.Everything went perfectly.Extra cross-clamp time of 100 minutes was needed.Ecc time of 120 min was needed.The device was replaced with a 21 mm sjm trifecta glide bioclave: model: tfgt-21a, implanted supra-ring.

Manufacturer Narrative

The partial manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(4) were pulled and reviewed by quality control at livanova (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.Review of the images taken during the steady-flow test confirmed that perceval valve sn #(b)(4) met all functional inspection criteria.A p-np gauge test confirmed the absence of dimensional irregularity.Simulation of the valve deployment, performed with the returned device, was not able to replicate the anomalous behavior reported in the initial incident narrative.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic to the involved device.As reported by the customer, two different attempts were made to implant the valve and in both cases the perceval valve slipped at the level of the rca ostium, leading to mal-positioning of the valve.It is possible that the particular patient annulus anatomy did not allow for proper valve implantation.It should be noted that, based on the current ifu for the perceval valve, only one attempt to implant the valve can be made.If this attempt is unsuccessful, the perceval should not be re-implanted.

Event Description

After implanting perceval m, the valve was not symmetric and was not perfectly situated in the annulus.In this moment of the operation it was not clear if the problem was caused by the anatomy of the patient or of a dysfunction of the device.To be careful it was decided to take the valve out and use a stented valve with the same size.Everything went perfectly.Extra cross-clamp time of 100 minutes was needed.Ecc time of 120 min was needed.The device was replaced with a 21 mm sjm trifecta glide bioclave: model: tfgt-21a implanted supra-ring.Additional information: the perceval valve was conventionally implanted intra-annularly, but slipped twice at the same site (rca ostium).

• 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
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 fraser north way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 fraser north way; burnaby, bc
• MDR Report Key: 6505359
• MDR Text Key: 73217622
• Report Number: 3004478276-2017-00062
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)200629
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• 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: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/29/2020
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 65