MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ACCUTRAK DELIVERY CATHETER SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number DCS-C4-18F-23US

Device Problem Material Separation (1562)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Rupture (2208); Blood Loss (2597)

Event Date 05/13/2015

Event Type  Death  

Event Description

Medtronic received information that prior to the deployment of this 23 mm transcatheter bioprosthetic valve, the delivery catheter system (dcs) had a small separation (capsule and nose cone not flush) at the nose cone/capsule junction after it passed through the 18fr introducer sheath.The issue was initially resolved in vivo by rotating the micro knob to close the small gap between the nose cone and capsule.However, the slight gap occurred again as the dcs was advanced over the aortic arch.It was suspected that upon re-separation, the unprotected (exposed) sheath may have caught calcification and caused an aortic rupture distal to the left subclavian artery.A repair of the vascular injury was attempted using 3 stent grafts.The patient lost over 3 liters of blood and was unable to come off bypass machine successfully.The patient subsequently expired.

Manufacturer Narrative

The device was discarded by the customer, therefore no product analysis can be performed.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

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.If the capsule could not be fully closed and therefore was not supporting the tip and allowed a gap between the tip and the capsule, the tip could snag.A conclusive assessment of the relationship between the device and the clinical observation could not be reached without the return of the device and with the limited information made available.

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: ACCUTRAK DELIVERY CATHETER SYSTEM
• 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: 4815987
• MDR Text Key: 5905376
• Report Number: 2025587-2015-00618
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2016
• Device Model Number: DCS-C4-18F-23US
• Device Catalogue Number: DCS-C4-18F-23US
• Device Lot Number: 0007422234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 00085 YR