MAUDE Adverse Event Report: LIVANOVA CANADA CORP CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVES

Model Number	CNA25
Medical Device Problem Codes	Obstruction of Flow (2423); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Thrombus (2101); Thromboembolism (2654)
Date of Event	07/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As per ifu for crown prt pericardial heart valve anti-coagulant use is advised after device implant "in general, for bioprostheses, anticoagulation therapy is recommended for 90 days after aortic valve replacement." the event has been resolved without device intervention.Device not explanted.
Event or Problem Description
On july 24th the manufacturer was notified of the following event: for a crown prt pericardial heart valve size 25 that was implanted on (b)(6) 2016, a thrombus was detected on one cusp of the valve in (b)(6) 2017.The patient did not receive anti-coagulation after device implant.On detection of the thrombus, the patient was treated with anti-coagulation (heparin) and the thrombus disappeared.The event was resolved through use of anti-coagulation and no device intervention was required, the device is still implanted.The patient is being monitored by the cardiologist at present.
Additional Manufacturer Narrative
On 06/28/2017 ¿ tee ¿ there is a bioprosthetic valve in aortic position.The leaflets are coated with echogenic material (at least in 2 leaflets) and there is a highly mobile mass moving from the lvot to aortic root.All these findings are consistent with endocarditis, provided the clinical presentation is supportive (do not know history).There is no aortic regurgitation.
Additional Manufacturer Narrative
The partial manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # cna25, s/n # (b)(4), were retrieved 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 cna25 mitroflow aortic pericardial heart valve at the time of manufacture and release.
Additional Manufacturer Narrative
The patient report received indicated that anticoagulation therapy was appropriately recommended post-operatively (corrected information).Based on the document review performed, no manufacturing deficits were identified.The patient's operation report indicated that anticoagulation therapy was appropriately recommended post-operatively.As the device was not explanted, no further investigation can be performed at this time, and it is not possible to determine the root cause of the event.According to the crown prt instructions for use, "adverse events potentially associated with the use of bioprosthetic heart valves (in alphabetical order) include.Thromboembolism [and] valve thrombosis".As such, the reported event is a known inherent risk of the procedure.The manufacturer acknowledges the late submission of this information.The delay was due to a submission error.
Event or Problem Description
On july 24th the manufacturer was notified of the following: on (b)(6) 2016 a crown prt pericardial heart valve size 25 was implanted for high grade aortic stenosis due to severe calcification with concomitant cabg procedure, with uneventful postoperative course, except for a leg wound dehiscence that was treated with no further complications nor infections.The patient was recommended for anticoagulation therapy for the first two months post-surgery (inr recommended: 2.0-3.0; median: 2.5) the patient¿s platelet count at discharge was normal.On (b)(6) 2017, the patient experienced a stroke resulting in cerebral insult with hemiplegia, aphasia, and dysphasia.On (b)(6) 2017 thrombosis of the valve was identified.The thrombosis was resolved, and was not visible in a follow-up visit.No infection was identified.On (b)(6) the patient developed atrial fibrillation in the context of hyperthyroidism.The patient was treated successfully with electrocardioversion.Grade ii mitral regurgitation and atrial septal aneurysm with patent foramen ovale (pfo) of 3 mm were also identified.The patient was ultimately diagnosed with dementia and was discharged to a nursing home on (b)(6) in generally good condition.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6815734
• Report Number: 3004478276-2017-00147
• Device Sequence Number: 16478517
• Product Code: LWR
• UDI-Device Identifier: 00896208000535
• UDI-Public: (01)00896208000535(240)CNA25(17)210331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2018

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
• Operator of Device: Physician
• Device Expiration Date: 03/31/2021
• Device Model Number: CNA25
• Device Catalogue Number: CNA25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 09/13/2017; 11/03/2017; 12/14/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 10/10/2017; 11/27/2017; 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR