MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS DLP AORTIC ROOT ANTEGRADE CANNULA W/VENT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 24009

Device Problem Occlusion Within Device (1423)

Patient Problem Aortic Dissection (2491)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

Medtronic received information indicating the patient's aorta was dissected while using an aortic root cannula.The customer repaired the damaged aorta and there were no additional adverse patient effects.The product has not been returned to medtronic, therefore the evaluation is still in progress.A supplemental report will be filed once the investigation is completed.(b)(4).

Event Description

Medtronic received information indicating that during a procedure, the customer reported the pressure line of this aortic root cannula seemed to be occluded.The customer replaced the cannula with another, creating a second hole in the patient's aorta.After the cannula had been replaced, it was determined that the patient's aorta had been dissected.The customer repaired the damaged aorta and there were no additional adverse patient effects.

Manufacturer Narrative

Conclusion: medtronic cannot confirm or deny the complaint of an occluded pressure line of the aortic root cannula as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.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.A review of complaints received from november 2014 through december 2015 for this part number showed no trends related to this occurrence.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends.(b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: DLP AORTIC ROOT ANTEGRADE CANNULA W/VENT
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• 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: 5293117
• MDR Text Key: 33400784
• Report Number: 2184009-2015-00120
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 24009
• Device Catalogue Number: 24009
• Device Lot Number: 2015080817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2015
• 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): Required Intervention