MAUDE Adverse Event Report: MEDTRONIC, INC ADVANCE; CATHETER, EMBOLECTOMY

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Vascular Dissection (3160)

Event Date 08/21/2014

Event Type  Injury  

Manufacturer Narrative

Journal article: acute coronary syndromes in octogenarians referred for invasive evaluation: treatment profile and outcomes authors: milosz jaguszewski, jelena-r.Ghadri, johanna diekmann, roxana d.Bataiosu, jens p.Hellermann, annahita sarcon asim siddique, lukas baumann, barbara e.Stahli, thomas f.Luscher, willibald maier, christian templin journal: clin res cardiol year: 2015 reference: doi 10.1007/s00392-014-0756-5 patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic device used in the patient cohort may have caused or contributed to the death(s) was provided.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled - acute coronary syndromes in octogenarians referred for invasive evaluation: treatment profile and outcomes - was submitted for review.The aim of this study is to investigate the outcomes of octogenarians referred for urgent coronary angiography (cag) in the setting of acute coronary syndromes (acs).The primary end-point was in-hospital all-cause mortality.The secondary end-point included a composite of major adverse cardiovascular events (mace) of; death, nonfatal myocardial infarction (mi), stroke and symptom-driven subsequent percutaneous or surgical revascularization.Patients¿ outcomes for all-cause in-hospital mortality and mace were assessed at day 30 post procedure.The study population was divided into two groups based on age as follows: patients = 80 years old (n = 296) and below 80 years (n = 2 ,316).Cag was performed in all patients through femoral or radial access using non medtronic catheterization equipment.Any throm bectomy was performed using the medtronic export aspiration catheter.It is not clear from that data how many thrombectomies were performed.The primary end-point of death was significantly higher in octogenarians as compared to those 80 years of age.The secondary end-point comprising the overall mace rate was also significantly higher among older population.Intra-op 5 episodes of dissection were found in the under 80 cohort.Furthermore, this study identified that systolic blood pressure, creatine kinase, nt-probnp, and c-reactive protein are strong predictors for outcomes in octogenarians.

• Brand Name: ADVANCE
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12317623
• MDR Text Key: 266370245
• Report Number: 1220452-2021-00035
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K152335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/13/2021
• 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: 72 YR