MAUDE Adverse Event Report: INVATEC SPA MO.MA ULTRA; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

Journal article: one-day, sequential carotid artery stenting followed by cardiac surgery in patients with severe carotid and cardiac disease journal: vascular medicine year: 2019 ref: doi: 10.1177/1358863x19872547.Date of event: date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this study is to evaluate the safety and feasibility of the one-day, sequential approach by carotid artery stenting (cas) immediately followed by cardiac surgery.The study included 70 consecutive patients with ica stenosis coexisting with severe corona ry/valve disease, who underwent one-day, sequential cas and cardiac surgery.All cas procedures were performed according to the ¿tailored¿ algorithm with a substantial use of proximal neuroprotection devices and stents were implanted in most cases.The majority of patients underwent isolated coronary artery bypass grafting or isolated valve replacement.No major adverse cardiac and cerebrovascular events (macce) occurred at the cas stage.There were three perioperative macce: one myocardial infarction and two deaths.All macce were related to cardiac surgery and were due to the high surgical risk profile of the patients.There were 19 non-macce complications.Three non-macce complications were related to cas and were associated with femoral artery puncture: two pseudoaneurysms, managed by local compression/ percutaneous thrombin injection, and one acute right limb ischaemia on the second postoperative day, treated with embolectomy.A further 16 non-macce complications were associated with cardiac surgery.Up to 30 days, no further macce were observed.No perioperative or 30-day neurological complications occurred.In this patient series, one-day, sequential cas and cardiac surgery was relatively safe and did not result in neurological complications.Thus, a strategy of preoperative cas could be considered for patients with severe or symptomatic ica stenosis who require urgent cardiac surgery.

• Brand Name: MO.MA ULTRA
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer (Section G): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 9797178
• MDR Text Key: 195843230
• Report Number: 3004066202-2020-00011
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K092177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2020
• 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: 71 YR