MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP STRAIGHT TIP ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 75318

Device Problem Mechanical Problem (1384)

Patient Problem Vascular Dissection (3160)

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.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.

Event Description

Medtronic received information via literature regarding minimally-invasive (mis) mitral valve (mv) surgery, comparing the outcomes of antegrade axillary vs.Retrograde femoral perfusion in the mis mitral valve surgery.All data were collected from a single center between (b)(6) 2016 and (b)(6) 2020.The study population included 50 patients (predominantly male; mean age 74 years), who were treated using arterial cannulation of right axillary artery (group a) due to severe aortic arteriosclerosis.This axillary cannulation was carried out with either a 18 fr.Or 20 fr.Short-tip medtronic cannula (serial numbers not provided).After fixation of the cannula, another stay suture was placed at the skin level to prevent dislocation of the cannula during cardiopulmonary bypass (cpb) perfusion.Among all patients, no intraoperative deaths occurred, however one patient in group a expired 5 days after surgery due to multi-organ failure.Based on the available information, none of the deaths were attributed to medtronic product.Among all patients, adverse events included: intraoperative aortic dissection (requiring median sternotomy and central aortic repair), and an accidental dislocation of the axillary artery cannula during cpb (requiring emergent conversion to femoral cannulation and an additional stay suture of the cannula at the skin was placed for fixation).Based on the available information, these adverse events may have been attributed to medtronic product.It was noted that the patient which had the dissection had a severe systemic atherosclerotic disease and most probably the intimal lesion was induced by the wire resulting in a type a aortic dissection.Despite this iatrogenic event the patient had an uneventful postoperative course and was discharged without neurological deficit 13 days following surgery.The patient who had the accidental dislocation of the axillary artery cannula had an uneventful postoperative course and was discharged home without neurological deficit 8 days following surgery.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Correction g2: "literature" added.Correction h10: literature details: petersen j, naito s, kloth b, pecha s, zipfel s, alassar y, detter c, conradi l, reichenspurner h and girdauskas e, ¿antegrade axillary arterial perfusion in 3d endoscopic minimally-invasive mitral valve surgery", frontiers in cardiovascular medicine, ecollection 2022, https://doi.Org/10.3389/fcvm.2022.980074 conclusion: medtronic cannot confirm or deny the complaints of adverse events in cases undergoing minimally-invasive (mis) mitral valve (mv) surgery using antegrade axillary perfusion as no product has been returned to date.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.A clinical review was completed with medtronic medical safety and concluded there was no allegation that the patient death was related to the dlp straight tip arterial cannula.All adverse events reported in the literature article are considered known and foreseeable and are assessed in the risk management documentation for these products.The patient who experienced the intraoperative aortic dissection had a severe systemic atherosclerotic disease and the intimal lesion was most likely induced by the wire leading to a type a aortic dissection.There was no allegation of device malfunction in the literature article that would have resulted in dissection and the event could have been a result of use conditions, patient disease state and technique.The accidental dislocation of the axillary artery cannula during cpb and requiring emergent conversion to femoral cannulation could also have been the result of use conditions, patient disease state and technique as no device malfunction was reported to have caused the dislocation.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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: DLP STRAIGHT TIP ARTERIAL 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17069214
• MDR Text Key: 316586240
• Report Number: 2184009-2023-00400
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

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: Health Professional
• Device Model Number: 75318
• Device Catalogue Number: 75318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 07/18/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Male