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

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

Patient Problems Intimal Dissection (1333); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the sprinter legend rx ptca balloon catheter survey results from an interventional cardiologist using the devices for the past year.In the past 12 months the physician has used sprinter legend rx 120 times and 1.25 x 6 mm, 4.0 x 30 mm and other intermediate sizes were used 2 x coronary vessel dissection (related to the procedure but not directly to sprinter legend rx) and 10 x restenosis of the dilated vessel (within procedure or after procedure and related to the procedure but not directly to sprinter legend rx) were encountered in the using the product over the last 12 months.And were previously reported to medtronic issues regarding radioopacity were noted, it was stated that the physician would like if it was improved.

• Brand Name: SPRINTER LEGEND RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; tijuana
• Manufacturer (Section G): MEDTRONIC MEXICO; tijuana
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9277210
• MDR Text Key: 165272538
• Report Number: 9612164-2019-04631
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• 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: 10/11/2019
• 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