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

Model Number SPL25015X

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2019

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 171826636
• Report Number: 9488668
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00613994902597
• UDI-Public: (01)00613994902597(17)220924(10)218568887
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 87