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

Model Number	R5-021
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2018 a patient received a carbomedics reduced r5-021 aortic valve.The site reported the valve was broken and fragmented from the pivot part after the sutures were attached in the aortic annulus position.No further information received.
Event or Problem Description
On (b)(6) 2018 a patient received a carbomedics reduced r5-021 aortic valve.The site reported the valve was broken and fragmented from the pivot part after the sutures were attached in the aortic annulus position.All fragments carefully were collected and patient was flushed.Site reported all fragments were removed.Another carbomedics reduced r5-021 aortic valve was used as a replacement.This event added 20 minutes to the x-clamp time.
Additional Manufacturer Narrative
The manufacturer received additional information on march 14, 2019.The information is included in the following updated event description: on (b)(6) 2018 a patient received a carbomedics reduced r5-021 aortic valve.The site reported the valve was broken and fragmented from the pivot part after the sutures were attached in the aortic annulus position.All fragments carefully were collected and patient was flushed.Site reported all fragments were removed.Another carbomedics reduced r5-021 aortic valve was used as a replacement.This event added 20 minutes to the x-clamp time.In addition the manufacturer received indication that the device is available for return and analysis.Once the device analysis is complete the competent authority will be updated regarding all investigation results.
Additional Manufacturer Narrative
The device was received and a gross investigation was performed.The returned device was received in an explant kit and was received disassembled in the provided plastic jar, along with the holder, the cap of the original internal container and the original plastic retainer.Following the gross investigation a visual inspection was performed.The sewing cuff was blood stained and visibly damaged with signs of cutting and residues of stitching.The orifice was broken in 4 fragments.In addition, one of the disassembled leaflets was intact meanwhile the other one was broken; only 2 fragments of the broken leaflet were returned.After the decontamination and cleaning the returned valve and its components were inspected by means of stereoscopic microscope to document their status and morphology.No additional macroscopic elements of damaging were found during this investigation step.Then, in order to better analyze the morphology of the fragments fracture surfaces, a scanning electron microscope analysis was performed.Based on the performed investigation, no material defects, voids, porosity, or inclusions were observed in the fracture surfaces that could suggest the presence of pre-existing defects.In addition to the above analysis the dhr of the carbomedics reduced valve sn (b)(4).Was retrieved and reviewed, confirming that the valve in object satisfied all material, dimensional and performance requirements of carbomedics reduced r5-021 at the time of manufacture and release.In addition, considering the type of damaging detected and the fracture locations, it is reasonably possible one of the following events occurred.The leaflet breakage may have been caused by a mishandling during the implanting / rotation procedure, likely due to the use of an incorrect rotation tool.The orifice breakage may have been caused using surgical instruments during the normal explanting procedure.Focusing the investigation on the leaflet breakage, the analysis conducted on the fracture surfaces leads to the conclusion that a load, exceeding the ultimate strength of the pyrolytic carbon, was inadvertently applied to the leaflet during the handling of the device for implantation.The above-mentioned maneuver would have caused a local over loading and bending moment of the component, finally resulting in its breakage.Given this analysis the root cause is reasonably not related to any factors intrinsic to the device in question and are likely attributable to procedural factors.Fields changed: date of report, pma/510k, if follow-up, what type,and device evaluated by mfr.
Additional Manufacturer Narrative
The manufacturer has made several attempts to follow-up for additional information and was unable to acquire additional event or patient information.Because the device was not returned for analysis and no follow-up was received no additional investigations can be performed.At this time the root cause of the reported event cannot be determined.If additional information is received in the future the manufacturer will reassess the investigation.
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.

• Brand Name: CARBOMEDICS REDUCED PROSTHETIC HEART VALVE, AORTIC
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 7997899
• Report Number: 3005687633-2018-00201
• Device Sequence Number: 16471778
• Product Code: LWQ
• UDI-Device Identifier: 08022057012777
• UDI-Public: (01)08022057012777(240)R5-021(17)211024
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/24/2019

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: 10/24/2021
• Device Model Number: R5-021
• Device Catalogue Number: R5-021
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 11/14/2018; 02/14/2019; 03/14/2019; 05/27/2019
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 12/11/2018; 02/14/2019; 04/09/2019; 06/24/2019
• 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