MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

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

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891)

Event Date 02/01/2022

Event Type  Injury  

Event Description

A journal article was submitted detailing a single-center retrospective study assessing data of elderly patients undergoing carotid artery stenting (cas), and to compare them with those of the younger (<(><<)> 75 years).580 patients were included in the study.There were 272 patients (46.9%) with age =75 years and 308 patients (53.1%) with age <(><<)> 75 years.During procedure medtronic¿s moma proximal embolic protection device (epd) or spider fx distal epd were amongst devices used.Of the self-expanding stents used in the population, medtronic¿s protégé and cristallo ideale devices were used.The primary end points of the study were 30-days stroke, 30-daysdeath and 30-days macce.Vascular complications and major bleedings were also separately evaluated.The success of the procedure was achieved in all but 2 patients (99.9%): in one case the procedure was not completed for technical issues and in the other the patient died for hemodynamic collapse after the post dilatation.Within the population, 30-days stroke is reported in 3.4% of the population.30-days death is reported in 0.7% of the population.Secondary endpoints reported as major stroke in 0.7%, minor stroke in 1.7%, and cerebral haemorrhage in 1% of the population.Vascular complications are reported for 0.85 of the population.12-months death reported as 4.8% of the population and long-term death reported in 23.8%.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.Th erefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.

Manufacturer Narrative

Title: characteristics and outcomes of elderly patients undergoing carotid stenting: experience of a high-volume interventional cardiology center author: varbella f., cerrato e., rolfo c journal: catheterization and cardiovascular interventions year: 2022 vol/issue: 99(3) ref: 10.1002/ccd.30002.Age: average age, gender: majority gender, date of event: date of publication medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14010680
• MDR Text Key: 293538479
• Report Number: 2183870-2022-00123
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P060001
• 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
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• 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: 04/01/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Male