MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number EVOLUTR-34

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, before loading the valve, it was noted there was a broken strut.The valve was not used and a new valve was used for implant.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was received in its original packaging and original container jar, submerged in clear solution.Damage to the outflow frame was observed.All leaflets were flexible, intact, and in the closed position.All commissures were intact.Multiple bends were observed on the frame lateral to the c paddle on frame cells c124, c125, c135, c24, c25 and c17.Damage is indicative of frame misalignment during the loading process.Conclusion: the investigation is in progress.Updated: h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The valve was returned to medtronic santa ana explant laboratory for analysis.The valve was received in its original packaging and original container jar, submerged in clear solution.Damage to the outflow frame was observed.All leaflets were flexible and intact and were in the closed position.All commissures were intact.Multiple bends were observed on the frame lateral to the ¿c¿ paddle.Damage is indicative of frame misalignment during the loading process.A broken strut, between c25 and c17, appears to have occurred during loading.A bent strut adjacent to the break appears to be associated with misalignment during loading.Following the inspection and analysis from the santa ana laboratory, the evolut r 34mm, was sent to the medtronic mounds view facility for further evaluation.The detailed analysis documents the results of the optical inspection and fractographic analysis completed using digital optical microscopy and scanning electron microscopy (sem).Visual and optical inspection of the as-received device confirmed the fracture location and revealed deformations in struts.The fractured portion of the evolut r 34mm frame was extracted (cut out) from the frame for sem analysis.Sem also revealed several instances of scratching on the outflow tip of five (5) cells.The fractographic analysis indicates that the fracture of the strut between cells c25 and c17 was caused by a single-cycle tensile o verloading event.In addition, the fractographic analysis indicates the fracture began at the outflow surface and propagated toward the inflow surface of the frame via ductile rupture due to overloading.Signs of extrinsic macroscopic damage were observed in the form of gross kinking in five struts.Signs of extrinsic surface damage associated with mechanical overloading were identified at the laser-cut outflow surfaces immediately adjacent to the sites of initiation on the fracture faces.The customer event description of the tav arriving in the glass shipping jar with 1 broken strut and 5 kinked struts is unlikely given the inspection record and the shipping procedure.The optical inspection and fractographic analysis evidence of a single-cycle tensile overloading event.There wasn¿t a medtronic representative present at the case to oversee this event that could provide further clarity in this event.The event description indicates that loading of the tav was never attempted.However, based on the analysis, it is plausible that a failed loading attempt could have caused the deformation and fracture in evolut r 34mm.The scratching around the outflow of the tav could be a sign of a loading attempt.Collectively, all available evidence suggests that the observed fracture and kinking resulted from ductile rupture due to overloading.The valve was not used and a new valve was used for implant.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.This event does not indicate device misuse or malfunction.Updated h.6 - eval method and eval conclusion codes.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10154799
• MDR Text Key: 195160922
• Report Number: 2025587-2020-01916
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2021
• Device Model Number: EVOLUTR-34
• Device Catalogue Number: EVOLUTR-34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 09/24/2020; 11/14/2020
• Supplement Dates FDA Received: 10/06/2020; 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1