MAUDE Adverse Event Report: COVIDIEN SPIDER FX; DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC

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

Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969); Perforation (2001); Stenosis (2263); Vascular Dissection (3160)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

Age: average age.Sex: majority gender.Event date: date of article publication.Safety and efficacy of embolic protection devices in saphenous vein graft interventions: a propensity score analysis¿multicenter svg pci protecta study journal of clinical medicine (2020) 10;1-10 10.3390/jcm9041198.If information is provided in the future, a supplemental report will be issued.

Event Description

The article reports on a retrospective study which was designed to compare major cardiovascular events of all-comer population of saphenous vein graft (svg) percutaneous coronary intervention (pci) with and without embolic protection devices (epds) at one year of follow-up.A total of 792 patients who received isolated svg pci were included.Spider fx was identified as en epd type used in the study.Epds were used in 190 (23.9%) patients.During the procedures where a epd was used, pre-dilation was performed in 29.5% of cases, and thrombectomy in 5.4% of cases.On average 1 stent was implanted and 2.6% of patients presented with residual stenosis.Vessel perforation is reported in 0.5% of cases and dissection in 2.1% of cases.0.5% of patient experienced cardiac arrest.The primary endpoint of the study (1-year overall macce) was observed in 20.5% of patients in the epds pci group, and in 26.4% of patients in the no-epds pci group.Within the epd group there were 8 deaths, 14 myocardial infarction¿s (mi¿s), 2 strokes, 17 target vessel revascularization (tvr¿s), and 13 target lesion revascularization (tlr¿s) reported.The main finding of svg pci protecta study was that during svg pci the use of epds was associated with comparable results to no-epds in all-comers population at 1-year follow-up.The article concludes that the use of epds was not associated with any significant improvement in macce in an all-comers population both at 30-days and one year follow-up.

• Brand Name: SPIDER FX
• Type of Device: DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10210711
• MDR Text Key: 203348091
• Report Number: 2183870-2020-00195
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K063785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2020
• 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: 70 YR