MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER LEGEND RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number SPL40020X

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

Patient Problems Embolism (1829); Embolism/Embolus (4438)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An article was submitted.The aim of this study was to determine the long-term patency rates of middle/distal common carotid artery (cca) stenting and to investigate predisposing factors in the development of in-stent restenosis (isr) fifty-one patients who underwent stenting with 51 self-expandable stents for significant stenosis of the middle and/or distal cca between 2000 and 2018 were analyzed retrospectively.The median follow-up time was 35 months.Pre-dilation was carried out in only two cases.In one of these cases, a sprinter legend rx balloon was used for pre-dilation purposes.Technical success was achieved in all patients.Two neurological complications were observed to have developed: one contralateral hemiparesis plus aphasia that lasted for 5 min after balloon inflation, and one transient contralateral upper extremity numbness.A non-medtronic cerebral protection device was utilized in both these patients, with debris (embolic material) found in the filter of the latter complication.All neurological symptoms disappeared spontaneously.Computed tomography examination performed within 2 h of the onset of symptoms revealed no evidence of acute brain ischemia or intracranial arterial obstruction in either patient.The 30-day all-cause mortality rate was zero.

Manufacturer Narrative

Correction: catalog number initial reporter phone number journal article: middle and distal common carotid artery stenting: long-term patency rates and risk factors for in-stent restenosis ref: https://doi.Org/10.1007/s00270-020-02522-5 a2: average age: 63 years a3: majority gender: male b3: date of publication: 21 may 2020.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: SPRINTER LEGEND RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10835292
• MDR Text Key: 216093795
• Report Number: 9612164-2020-04410
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SPL40020X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR