MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Corneal Pannus (1447)
Date of Event	05/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete manufacturing and material 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.A gross investigation was performed on the returned device.The returned valve was received deeply blood stained with traces of pannus visible on the sewing cuff.Even presence of blood was observed also in the valve hinges, the leaflets were free to move.
Event or Problem Description
A patient received a carbomedics standard m7-031 mechanical mitral valve on (b)(6) 2005.The manufacturer was notified that the device was explanted as a result of pannus overgrowth on (b)(6) 2019.The patient had received follow-up at another hospital, and was referred to the (b)(6) cardiovascular center for symptoms of shortness of breath.On echo it was identified that one of the leaflets was stuck in the closed position.When the thoracotomy was done again, the leaflet was still closed and the thrombus was attached.It opened when pressed.The anticoagulation therapy may not have worked well, but the details are unknown because the patient had been followed up at another hospital.Biopsy results were negative for infections.
Event or Problem Description
A patient received a carbomedics standard m7-031 mechanical mitral valve on (b)(6) 2005.The manufacturer was notified that the device was explanted as a result of pannus overgrowth on (b)(6) 2019 and replaced with an abbott mhv.The patients post operative course was reported to be good.The patient had received follow-up at another hospital, and was referred to the gunma prefectural cardiovascular center for symptoms of shortness of breath.On echo it was identified that one of the leaflets was stuck in the closed position.When the thoracotomy was done again, the leaflet was still closed and the thrombus was attached.It opened when pressed.The anticoagulation therapy may not have worked well, but the details are unknown because the patient had been followed up at another hospital.Biopsy results were negative for infections.
Additional Manufacturer Narrative
The manufacturer received additional information on (b)(6) 2019.The following updated event description is included in section b5: a patient received a carbomedics standard m7-031 mechanical mitral valve on (b)(6) 2005.The manufacturer was notified that the device was explanted as a result of pannus overgrowth on (b)(6), 2019 and replaced with an abbott mhv.The patients post operative course was reported to be good.The patient had received follow-up at another hospital, and was referred to the gunma prefectural cardiovascular center for symptoms of shortness of breath.On echo it was identified that one of the leaflets was stuck in the closed position.When the thoracotomy was done again, the leaflet was still closed and the thrombus was attached.It opened when pressed.The anticoagulation therapy may not have worked well, but the details are unknown because the patient had been followed up at another hospital.Biopsy results were negative for infections.The following investigations have been performed: the returned valve was received in a plastic pouch and contained in a petri dish.It was received deeply blood stained with traces of pannus visible on the sewing cuff and presence of blood and organic material were observed also in the valve hinges: the leaflets, though not easily, were free to move.After decontamination (formalin treatment) the carbomedics status was photographically documented and sent to an external laboratory to perform histopathological examination of the organic deposition observed in the valve hinges.Thrombus depositions are visible on the hinges and on both the leaflets; small fibrous pannus depositions are present on the sewing ring.In addition, gram + bacteria and fungi are visible inside the thrombus depositions that are present on the back hinges.Then the valve was cleaned and the sewing cuff removed from the valve functional subassembly, that was visually inspected by qc personnel.No pre-existing defects were noticed.The hydrodynamic testing conducted on the carbomedics subassembly, size 31, sn 603858, was performed using the r0706 - vivitro pulse duplicator equipment.The effective orifice area (eoa) at 70 bpm, 5 l/min of cardiac output and mean aortic pressure of 100 mmhg is 1.96 cm2, above the iso 5840 minimum requirement 1.90 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of 100 mmhg, the regurgitant fraction [%] is 11.7 % and it is below the requirement of iso 5840 (rf% < 20%) for a prosthesis of equivalent tad.The valve showed a correct movement of the leaflets during opening and closure phases and no other anomalies were observed.The result of the device history record review of the returned carbomedics prosthesis sn a603858-h confirmed that the returned product satisfied all material, dimensional and performance standards, required for a cphv m7-031 at the time of manufacture and release, including a function test performed on (b)(6)2004.Based on the performed analysis it is possible to exclude any relationship between the reported event and the valve quality because no functional anomalies were detected under hydrodynamic testing conditions.In addition, according to the presence of bacteria and fungi in the analyzed thrombus, it is possible to speculate that an adverse and acute systemic reaction occurred, causing organic deposition in the valve hinges, finally altering the correct leaflets movement.Our experience leads to assume that an incorrect anticoagulation treatment, as also indicated by the surgeon, can be considered the most probable cause of the event.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 8689788
• Report Number: 3005687633-2019-00198
• Device Sequence Number: 11518253
• Product Code: LWQ
• UDI-Device Identifier: 08022057012746
• UDI-Public: (01)08022057012746(240)M7-031(17)090201
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: Health Professional
• Device Expiration Date: 02/01/2009
• Device Model Number: CPHV
• Device Catalogue Number: M7-031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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