MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. PERCEVAL SUTURELESS AORTIC VALVE; TISSUE HEART VALVES

Model Number PVS25

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Complete Heart Block (2627)

Event Date 12/02/2013

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted in the patient, a full analysis of the prosthesis cannot be performed.A complete manufacturing and quality records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Further investigation is ongoing.Device not explanted.

Event Description

The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2013, a (b)(6) male patient received a pvs25 to replace the native steno-insufficient aortic valve.The aortic valve replacement (avr) procedure was performed through median sternotomy and no concomitant procedures were performed.On (b)(6) 2013, the patient received a pacemaker due to an av block of grade iii.The echo performed on (b)(6) 2013, showed a good valve functionality (10mmhg mean gradient, no leaks).The patient was discharged on (b)(6) 2013.The patient underwent the avr surgery in sinus rhythm with right bundle branch block (rbbb).

Event Description

The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2013, a 63 years old male patient received a pvs25 to replace the native steno-insufficient aortic valve.The aortic valve replacement (avr) procedure was performed through median sternotomy and no concomitant procedures were performed.On (b)(6)2013, the patient received a pacemaker due to an av block of grade iii (the relationship with the device is reported to be unknown).The echo performed on (b)(6) 2013, showed a good valve functionality (10mmhg mean gradient, no leaks).The patient was discharged on (b)(6) 2013.The patient underwent the avr surgery in sinus rhythm with right bundle branch block (rbbb).The following additional information was received by the site: the patient had no rhythm disturbance pre-operatively, so there is a high probability that the block is related to the implant of the prosthesis; it was emphasized, however, that the surgical prostheses are correlated with an incidence of postoperative av block; moreover, the incidence is not related only to the type of prosthesis, but above all to the accuracy of the decalcification of the aortic ring near the conduction bundle; a further variable is given by the degree of oversizing of the prosthesis, whose radial force (like the self-expandable trans-catheter prosthesis) could be the basis of the aforementioned block.

Manufacturer Narrative

Based on the information available, it is not possible to establish the exact root cause of the event.However, based on the preoperative information reported in the sure avr registry, the patient underwent surgery in sinus rhythm with rbbb, which is predictive of av block grade iii.Conduction disorders are common in patients with aortic valve diseases.As a result, it is common for patients to receive a permanent pacemaker implantation after aortic valve replacement.Risk factors include preexisting conducting disease and preoperative aortic regurgitation.This event is therefore a known, inherent risk of the procedure.

• Brand Name: PERCEVAL SUTURELESS AORTIC VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 8191993
• MDR Text Key: 131302502
• Report Number: 3005687633-2018-00241
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2016
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 63 YR
• Patient Weight: 88