MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV SPRINTER® LEGEND; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	SPL25015X
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An elderly male patient presents with a history significant for type 1 diabetes, hypertension, hyperlipidemia, coronary artery disease status post coronary artery bypass grafting (cabg), gastroesophageal reflux disease (gerd), and acute respiratory failure.While performing a heart catheterization, synergy stent deployed angiograms done.Stent appeared to have fracture.Intravascular ultrasound (ivus) procedure done to verify.Second stent deployed over fractured stent.

• Brand Name: SPRINTER® LEGEND
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; 8200 coral sea st ne # mvs74; moundsview MN 55112
• MDR Report Key: 9488668
• Report Number: 9488668
• Device Sequence Number: 11148518
• Product Code: LOX
• UDI-Device Identifier: 00613994902597
• UDI-Public: (01)00613994902597(17)220924(10)218568887
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/05/2019
• Report Date (Section F): 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SPL25015X
• Device Lot Number: 218568887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 87
• Date Report Sent to FDA: 12/05/2019