MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ACCUTRAK DELIV SYS 23MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number DCS-C4-18FR-23MM

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Death (1802); Ventricular Fibrillation (2130); Aortic Dissection (2491)

Event Date 06/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: a rare complication: an attempt of retrieval of an aortic valve wrapped with pig tail catheter during transcatheter aortic valve implantation authors: bekir serhat yildiz, yusuf izzettin alihanoglu, ihsan alur, harun evrengul, dayimi kaya citation: cardiovasc revasc med.Accepted for epublish june 22, 2015 (doi: 10.1016/j.Carrev.2015.06.004) publisher accepted date used for event date.

Event Description

Medtronic received information via literature review that a (b)(6) male patient with severe aortic regurgitation (ar) underwent a procedure to implant a medtronic 31-mm transcatheter bioprosthetic valve (serial number not reported).During positioning of the bioprosthetic valve, it became dislodged from the annulus and embolized into the ascending aorta.During an unsuccessful attempt to recapture the device into the delivery catheter system (dcs) (lot number not reported), the pig tail catheter (ptc) became entangled within the bioprosthetic valve struts.A guidewire was used to straighten the ptc, however this did not release it from the bioprosthetic valve struts.A snare was successfully used to capture the ptc and pull it back into the abdominal aorta.The bioprosthetic valve was also snared and pulled back to the aortic bifurcation.During attempts to retrieve the dcs from the patient, the sheath's nose cone "ruptured".Traumatic acute aortic dissection extending to femoral artery was noted, and the patient was transferred to the surgical team.In surgery the aortic dissection was repaired and the ptc and the sheath's nose cone were retrieved.The patient died of ventricular fibrillation within one hour of the surgery.There was no allegation attributing the death to medtronic products.Additional information has been requested.

Event Description

Additional information stated that in the physician¿s opinion, neither the transcatheter bioprosthetic valve or dcs caused or contributed to the aortic dissection or the patient death.No angiograms were available from the procedure, and no autopsy was performed.

• Brand Name: ACCUTRAK DELIV SYS 23MM
• 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: 5030262
• MDR Text Key: 24044232
• Report Number: 2025587-2015-00889
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/28/2015

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?: Yes
• Device Operator: No Information
• Device Model Number: DCS-C4-18FR-23MM
• Device Catalogue Number: DCS-C4-18FR-23MM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Supplement Dates Manufacturer Received: 08/28/2015
• Supplement Dates FDA Received: 09/19/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00071 YR