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

Model Number PVS21

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494); Migration (4003)

Patient Problems Cardiac Arrest (1762); Cardiogenic Shock (2262); Obstruction/Occlusion (2422); Vascular System (Circulation), Impaired (2572)

Event Date 01/30/2020

Event Type  Injury  

Event Description

The manufacturer was notified that a patient received a perceval pvs21 in aortic position ((b)(6) 2020).The procedure went well but in the icu the patient experienced circulatory problems.It was reported that the valve had migrated up in the ascending aorta blocking the coronaries.The patient arrested and was emergently taken to the operating room.An emergency incision and open heart massage were performed and the patient restored the sinus rhythm.The perceval pvs21 was removed and a crown 19mm was implanted.An uneventful postoperative course was reported.

Manufacturer Narrative

F10 was properly corrected with the proper device codes.The remainder of the information previously submitted remains unchanged.

Manufacturer Narrative

A complete manufacturing and material records review for the device pvs21 sn (b)(6) has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.A review of the coronary imaging received from the field was also performed, which confirmed the reported event (the perceval valve was positioned distally to the intended location).Since the device was discarded during the re-do surgery, no further investigation can be performed at this time.As such, it is not possible to define a definitive root cause for the reported event.However, based on the available information and the medical judgment received, there was no evidence suggesting that the event was caused by any structural valve-related problem.A possible root cause can be identified in the patient conditions (i.E."large commissural height [.] may have been the cause of poor deployment and migration").Nevertheless, as explained in the perceval instructions for use, "a removed perceval prosthesis must not be re-implanted, because its integrity is no longer ensured." as such, the decision to re-collapse and re-implant the valve was made off-label.

Event Description

On (b)(6) 2020, a patient underwent an aortic valve replacement (avr) due to isolated stenosis (146/90 mmhg, ava 0.6 cm2).Due to the small aortic root, a pvs21 was selected.The first deployment of the device was not successful as the prosthesis did not attach intra-annularly on the lcc-level.It was reported that the left cusp migrated up the aorta, which was due to the valve's partial supra-annular position in the first implantation.The device was consequently explanted and re-implanted.The second time the implantation of the device was successful.The position and functionality of the device were checked and no abnormalities were detected.The patient was transferred to the icu and was hemodynamically stable.However, during the same evening, the patient cardiac enzymes (ck-mb) levels rose markedly, and the echo revealed hypokinesia anterio-apically.Coronary angiography was performed on the morning of (b)(6) 2020 which showed that the prosthesis had migrated distally in the aorta affecting the coronary ostia, mainly the left.Therefore, emergency surgery was decided and shortly after the patient went into cardiogenic shock and arrest.The patient was immediately transferred to the or under cpr.The aortotomy was reopened and the perceval migration in the lcc and ncc was confirmed.The skirt was obstructing the lcc-region and probably leading to hypoperfusion or occlusion of the left main ostium.The perceval s prosthetic valve was removed and on inspection showed no signs of structural failure or leaflets tear/damage.The prosthesis was deemed intact.A size 19 crown prosthesis was implanted intra-annularly.The patient was weaned from the cardio-pulmonary bypass uneventfully.The patient remained in the icu for 6 days requiring inotropic support but recovered on a daily basis and discharged to the ward.Based on the medical judgment received, in this patient the distance between the commissures and the annulus was large, meaning that the cusps were deep.This large commissural height could offer one explanation of why the stent of prosthesis did not anchor itself satisfactorily in the sinus of valsalva, and may have been the cause of poor deployment and migration.Furthermore, at the time of re-operation, there was nothing that indicated that this incident was caused by any structural valve-related problem.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9789810
• MDR Text Key: 188233667
• Report Number: 1718850-2020-01024
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2020,04/03/2020

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: 06/04/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/05/2020
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 02/05/2020; 02/05/2020
• Supplement Dates FDA Received: 04/03/2020; 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR