MAUDE Adverse Event Report: PERFUSION SYSTEMS AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 21014

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Vascular Dissection (3160)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

Lot number of the 21014 cannula has been requested from the customer.If provided, expiration date and device mfg date will be available.Uf/importer report-(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a dlp aortic root cannula with vent line, it caused an aortic dissection during placement of the cannula during cardiopulmonary bypass.It is unknown at this time if the device was replaced or how the dissection was treated.

Manufacturer Narrative

Device return was requested from the customer but was not provided to medtronic for analysis.Medtronic investigation: medtronic cannot confirm or deny the complaint of a failure of the aortic root cannula resulting in an aortic dissection, as no photo has been provided and no product has been returned.A root cause of this occurrence cannot be determined without returned product.The device history record could not be reviewed as no lot number was provided.No trends warranting escalation related to this occurrence were noted.Medtronic will continue to monitor for future occurrences and trends.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a dlp aortic root cannula with vent line, the patient sustained an aortic dissection during placement of the cannula for cardiopulmonary bypass.The customer reported nothing atypical was noted with the cannula.The dissection was repaired, the cannula was moved and the case was completed.The patient subsequently developed kidney failure as a result of low blood flow to the lower body including the kidneys.Patient opted not to be on long-term dialysis and eventually passed away from kidney failure.

• Brand Name: AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8594310
• MDR Text Key: 144531621
• Report Number: 2184009-2019-00019
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

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: 21014
• Device Catalogue Number: 21014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 05/01/2019
• Supplement Dates FDA Received: 06/26/2019
• 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: 79 YR
• Patient Weight: 93