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

Model Number PVS21

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 07/20/2018

Event Type  Injury  

Manufacturer Narrative

Device not explanted.

Event Description

A patient experienced persistent low platelet count following perceval valve implant.The patient's discharge was delayed for several weeks.No other information was provided.

Manufacturer Narrative

Fields were updated to reflect additional information received.

Event Description

The surgeon reported that he suspected the event was attributable to heparin-induced thrombocytopenia, and not to the device.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208 , s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(4).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.

Manufacturer Narrative

Based on the event information provided, the patient's pre-operative platelet count was below the normal range (130,000 pre-operative vs 150,000 normal), suggesting that the patient was susceptible to thrombocytopenia due to their specific clinical condition.As the serial number of the device was not provided, and the device remains implanted, no investigation could be performed.However, given that the device remains implanted, there is no information to suggest device dysfunction.Thrombocytopenia is a known complication of cardiopulmonary bypass.As such, this, and the patient's pre-operative condition, may have contributed to the reported event.Updated fields: event, other relevant history, if follow-up, what type.

Event Description

A patient experienced persistent low platelet count following perceval valve implant.The patient's discharge was delayed for several weeks.The patient's pre-operative platelet count was 135,000.The post-operative counts were: pod1 79,000; pod2 77,000; pod3 46,000; pod4 31,000; pod5 40,000; pod6 51,000 pod7 48,000 pod8 38,000; pod 14 40,000; pod21 (discharge) 53,000.Tests for heparin induced thrombocytopenia were negative.Cardiopulmonary bypass time was 42 minutes, and the cross-clamp time was 37 minutes.

• 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: 7779619
• MDR Text Key: 116995292
• Report Number: 3005687633-2018-00182
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention