MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T505

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Aortic Regurgitation (1716); Death (1802); Low Blood Pressure/ Hypotension (1914); Thrombus (2101); Rupture (2208)

Event Date 06/02/2015

Event Type  Death  

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve into this bioprosthetic valve, implant ed approximately 5 years, the transcatheter valve dislodged due to being positioned too high.The physician re-sheathed the valve to attempt the placement a second time.At the time of the second implant attempt the patient¿s pressure dropped dramatically and it was thought that severe aortic regurgitation was seen over this bioprosthetic valve, but this was not confirmed via echocardiogram.The physician made the decision to implant the transcatheter valve very quickly.The new deployed position of the valve was deep, around 8-10mm, but was determined to be acceptable by the physician.The patient¿s pressure did not return.An attempt was made to resuscitate the patient and perform an echocardiogram to assess the issue.Thrombus was noted around the annulus of the previously implanted bioprosthetic valve.The patient died on the table.The physician noted he was not sure what happened to cause the death, possibly aortic rupture.

Manufacturer Narrative

Patient information was requested but unavailable due to confidentiality restrictions.The serial number of the product has been requested.The product will not be returned for laboratory analysis, as it was not explanted.Cine images have been requested.The investigation is ongoing.Details of the investigation will be provided in a supplemental report.(b)(4).

Manufacturer Narrative

Medtronic received additional information from the sales representative after conversation with the physician.With the new information the event description is updated as follows: medtronic received information that during the implant of this transcatheter bioprosthetic valve into a previously implanted biopros thetic valve (implant duration of approximately 5 years), the transcatheter valve popped out due to positioning too high.The physician re-sheathed the valve to attempt the placement a second time.At the time of the second implant attempt the patient¿s pressure dropped dramatically down and it was thought that severe aortic regurgitation might be over the previously implanted bioprosthetic valve.The physician decided to implant the transcatheter valve quick and did not have control before releasing the valve.Echocardiogram showed the new deployment position of the valve was deep, around 10mm.The patient¿s pressure did not come back.They decided to snare the valve up.After they snared the valve up, it was at 0 mm and they decided to perform a balloon dilatation.They attempted to resuscitate the patient and perform and echocardiogram to observe what the issue may be.The only thing noted thrombus around the annulus of the previously reported bioprosthetic valve.The physician had made a puncture of the thorax and pulled out a lot of blood.They were not sure where the blood had come from.The surgeon wanted to open the patient again, but the patient had an advance directive, so that they couldn¿t open the chest to observe.The physician made a comment that it might be an annulus rupture or an rupture in these area, because the blood they get out that origin is dark like it is coming from the venous area.Also it correlated to the thrombus, which was seen by echo.The patient died on the table.They physician and also the surgeon were not sure what happened to the cause of death, possible aortic rupture.The patient has an advance directive, so they couldn¿t open the patient by surgeons request directly.Immediate family refused an autopsy.(b)(4).

Manufacturer Narrative

Device analysis: angiographic images (cines) were submitted and reviewed.This review found moderate to severe aortic insufficiency of this valve prior to the implant of the transcatheter aortic valve (tav).A conclusive cause of the regurgitation could not be determined from the limited information available.Based on the cines review, the balloon dilatation and/or the presumed snaring of the valve during the valve-in-valve procedure could be the contributing factors of the suspected annulus / aortic rupture.Conclusion: without the failure mechanism and the return of the valve for analysis, a root cause of the regurgitation cannot be determined.In addition, given the limited information available, a cause of the assumed annular rupture leading to patient death could not be determined.Cuspal tear and/or commissure dehiscence are the most common known failure modes which could lead to regurgitation.Calcification would be one of the most common causes for these failure modes.However, without the failure mechanism and the return of the valve for analysis, a root cause of the regurgitation cannot be determined.From the available information, there is no indication that the patient death was related to a failure or malfunction of the device, but instead, is related to physician technique and patient anatomy.

Manufacturer Narrative

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: HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4835300
• MDR Text Key: 5913270
• Report Number: 2025587-2015-00637
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/11/2015

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
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 12/11/2015
• Supplement Dates FDA Received: 11/09/2015; 12/18/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention