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

Model Number PVS27

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hemoptysis (1887); Aortic Dissection (2491)

Event Date 09/13/2016

Event Type  Injury  

Manufacturer Narrative

Not yet received.

Event Description

The manufacturer was notified on 27-sept-2016 of the following: a perceval valve was successfully implanted in the patient during an avr.The echo showed the valve to be in good working order with no pvl.The patient then began choking up blood while intubated post op in the icu.The surgeon was present and immediately reoperated the patient.An aortic rupture was identified.The perceval had migrated and possibly tore the aorta.Perceval was explanted and an edwards magna ease was implanted.The patient is obese and has a very fragile aortic wall.

Manufacturer Narrative

Device was received nov 8, 2016 for analysis.Gross exam was completed nov 10, 2016.Design history record review was completed mar 1, 2017.The complete manufacturing and material records for the perceval s heart valve, model icv1211, 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 perceval s heart valve at the time of manufacture and release.Visual inspection apr 5, 2017: according to the procedure (current revision at the time of manufacture and release), no non conformities were observed.The x-ray analysis ((b)(6) 2017) didn't show irregularities.No irregularity was identified with the p-np gauge test ((b)(4) 2017).No particular not conformities were observed.

Manufacturer Narrative

The visual inspection performed on the returned prosthesis confirmed the absence of manufacturing defects.No rupture of the stent was highlighted with the x-ray analysis and no irregularity was identified.Based on the performed analysis the reported event cannot be explained by any factor intrinsic in the involved device.

• 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 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 4125650
• MDR Report Key: 6065116
• MDR Text Key: 58699600
• Report Number: 3004478276-2016-00129
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)180929
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2018
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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