MAUDE Adverse Event Report: MEDTRONIC VASCULAR RESOLUTE INTEGRITY MICROTRAC CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Device Problems Material Fragmentation (1261); Inadequacy of Device Shape and/or Size (1583); Component Missing (2306)

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)

Event Date 02/06/2017

Event Type  Injury  

Event Description

Doctor inserted stent into coronary artery, and determined it was the wrong size.Balloon was intact but stent was missing from balloon under fluoro.Doctor suspected stent retained in the guide and guideliner catheter.They instructed the scrub tech to inflate stent balloon to see if it could be visualized.It was not.The guide and guideliner were removed.Doctor then took sterile scissors to cut up guide and guideliner in search of stent, due to the material the guide is made of, it could not be determined if the stent was or was not in the guide.Then doctor inserted a new guide, performed hd ivus and did not visualize the stent in the body.The 2 stents listed in emr as not deployed were the 2.5 x 18 resolute integrity rx, and the 3.0 x 12 resolute, so not sure which one it was.Patient brought back for stent retrieval next day.Stent retrieved in fragments, and sent to pathology.Stroke code called after stent removed due to neuro symptoms.Symptoms abated and no further issues.

• Brand Name: RESOLUTE INTEGRITY MICROTRAC CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC VASCULAR; 3576 unocal pl; santa rosa CA 95403
• MDR Report Key: 6553713
• MDR Text Key: 74728757
• Report Number: 6553713
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Other Device ID Number: 2.5 X 18 RESOLUTE INTEGRITY R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2017
• Event Location: Other
• Date Report to Manufacturer: 04/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR