MAUDE Adverse Event Report: MEDTRONIC RESOLUTE INTEGRITY DRUG ELUTING STENT

Model Number RSINT25026U

Device Problem Material Frayed (1262)

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

Event Date 01/22/2015

Event Type  Other  

Event Description

Pt had calcified coronary artery.A 2.5 x 26m resolute integrity drug eluting stent inserted into lad and removed without deployment.Stent struts were frayed upon removal.Stent was still on balloon.No damage to artery or patient.Physician did not dictate anything other than the stent would not cross.He had done laser prior to putting the stent in.He removed the stent and inserted a balloon and dilated the artery.It was then stented with a 2.25 x 22mm pt had no complications.

• Brand Name: RESOLUTE INTEGRITY DRUG ELUTING STENT
• Type of Device: DRUG ELUTING STENT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4570074
• MDR Text Key: 5458402
• Report Number: MW5041102
• Device Sequence Number: 1
• Product Code: NIQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RSINT25026U
• Device Catalogue Number: RSINT25026U
• Device Lot Number: NOT AVAILABLE
• Other Device ID Number: NOT AVAILABLE
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR