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 Hematoma (1884); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 09/28/2022

Event Type  Injury  

Event Description

Medtronic received a literature article 'debulking plus drug-coated balloon angioplasty versus drug-coated balloon angioplasty alone for femoropopliteal tosaka iii in-stent restenosis lesions'.This was a single-center retrospective study of patients who underwent endovascular interventions of debulking plus dcb or dcb alone for tosaka iii fp-isr lesions.One-year primary patency was the main outcome.A total of 80 patients with tosaka iii fp-isr were included; 39 were treated with debulking plus dcb, among whom 22 were treated with laser atherectomy (la) plus dcb and 17 were treated with rotational atherectomy (ra) plus dcb.41 were treated with dcb alone.A successful procedure was defined as residual stenosis (b)(4).After dcb angioplasty, bailout stenting (including stent-in-stent and stent distally or proximately to the isr lesion) was deployed according to the endovascular surgeon¿s judgment based on the evidence of in-stent fracture and flow-limited dissection at the proximal or distal segment of the stent as to the optimal treatment of the lesions.Self-expanding stents (medtronic and 2 other non-medtronic brands were available) were available in diameters of 4¿6 mm and in lengths up to 150 mm.The twelve-month primary patency rate was (b)(4) in the debulking + dcb group, and (b)(4) in the dcb group.The 12-month primary patency rates in the la + dcb and ra + dcb group were (b)(4) and (b)(4) respectively.One patient suffered acute thrombosis 2 days after the procedure and received re-intervention by in-stent catheter-directed thrombosis and bailout stent.Embolization was seen in a below-the-knee artery and removed by a 4f catheter in 2 patients in the dcb group, 1 patient in the la + dcb group, and 3 patients in the ra + dcb group.Three hematomas were all healed by conservative observation and pressure therapy.

Manufacturer Narrative

Literature title: debulking plus drug-coated balloon angioplasty versus drug-coated balloon angioplasty alone for femoropopliteal tosaka iii in-stent restenosis lesions videosurgery miniinv 2023; 18 (1): 166¿172 doi: https://doi.Org/10.5114/wiitm.2022.119936.A2 average age a3 majority gender b3 date of publication.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: 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: 18281328
• MDR Text Key: 329889330
• Report Number: 2183870-2023-00428
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• 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: 11/09/2023
• 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: 71 YR
• Patient Sex: Male