MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995

Device Problems Degraded (1153); Device Operates Differently Than Expected (2913)

Patient Problems Aneurysm (1708); Cardiopulmonary Arrest (1765); Stroke/CVA (1770); Chest Pain (1776); Transient Ischemic Attack (2109); Heart Failure (2206)

Event Date 01/25/2014

Event Type  Injury  

Manufacturer Narrative

A review of device history records could not be performed, as the serial numbers have not been provided to medtronic to date.Based on the limited information received, a root cause could not be determined.Pseudoaneurysm is a known failure mode and is addressed in the current device risk management files.

Event Description

Medtronic received information from a journal article examining post-implant aneurysmal deterioration of models from this aortic root bioprosthesis device family.The article - which was based on data aggregated from institutional data from the authors¿ health care facility, the fda¿s maude registry database, and the medical literature - identified 42 cases of aneurysmal deterioration over a 14-year time period.The aggregated data showed an average of 37.5 months from implant to when a device aneurysm or pseudoaneurysm was identified, occurring at a rate of 1.1% of the reviewed implants.(the authors reported a 4.7% rate of occurrence at their medical facility from devices implanted over a period of 76 months.) the average age for the aggregated population was 59 years (57 years at the authors¿ facility), with a majority of male patients.The reported valve sizes ranged from 23-29 mm.The authors included additional information on the subset of four patients from their facility who had device pseudoaneurysms; all were identified during routine annual follow-ups, resulting in three successful explants/reoperations (reoperation was not performed for one patient with end-stage renal disease and multiple co-morbidities).The article reported that a maude database review found 30 reported cases of aneurysms or pseudoaneurysms associated with products from this device family, with identification of the complications occurring from 2.5 to 127 months post-implant, and four related deaths.The remaining eight cases were identified by the authors in literature review.The article noted that the potential sequelae of pseudoaneurysm formation can include transient ischemic attack, stroke, heart failure, cardiopulmonary arrest and sudden death.It also was noted that some patients were asymptomatic, with pseudoaneurysm formation found during routine surveillance imaging, and other patients presented with chest pain or a transient ischemic attack.

Manufacturer Narrative

Additional information has been requested from the article¿s author contact; to date, no additional information has been received.Without additional details regarding the devices and submitted reports, it could not be determined if the 42 complaints cited in the article were previously reported to medtronic or if devices had been returned for analysis.A separate report has been filed regarding the patient deaths cited in the article.(b)(4).Pseudoaneurysm formation after medtronic freestyle porcine aortic bioprosthesis implantation: a word of caution authors: brian r.Englum, md; elizabeth n.Pavlisko, md; molly c.Mack, ba; asvin m.Ganapathi, md; matthew a.Schechter, md; jennifer m.Hanna, md, mba; and g.Chad hughes, md.Ann thorac surg 2014 presented at the poster session of the fiftieth annual meeting of the society of thoracic surgeons, orlando, fl, jan 25¿29, 2014.Published: annals of thoracic surgery, 2014 oct 6.Pii: s0003-4975(14)01421-0.Http://dx.Doi.Org/10.1016/j.Athoracsur.2014.06.062.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• 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: 4220025
• MDR Text Key: 12582013
• Report Number: 2025587-2014-00827
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,health professional,lit
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 00059 YR