MAUDE Adverse Event Report: MEDTRONIC IRELAND ZOTAROLIMUS-ELUTING CORONARY STENT; RESOLUTE ONYX 2.25 X 26MM

Model Number 2.25 X 26MM

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Sticking (1597)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/01/2017

Event Type  malfunction  

Event Description

During procedure a pilot 50 interventional wire was used to cross the lesion without incident.The physician then went with an emerge 2.0ptca balloon and inflated multiple times.A nc euphora 2.25x20rx ptca balloon was used and again fully inflated.Then the resolute onyx 2.25x26mm stent was used and the doctor was having problems advancing the stent across the lesion so decided to remove the undeployed stent.Upon removing the stent balloon it appeared to get stuck on the guideliner catheter.Once a balloon catheter was inside the catheter the physician noticed stent was off the balloon.Migrated distally and ended up i believe from the ct report stent is seen in the upper pole segmental branch of the left renal artery presumably the stent.The patient was pain free and stable upon leaving the cath lab and no further complications.Doctor discussed with patient and family.

• Brand Name: ZOTAROLIMUS-ELUTING CORONARY STENT
• Type of Device: RESOLUTE ONYX 2.25 X 26MM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park; west galway ; EI
• MDR Report Key: 6937282
• MDR Text Key: 89378744
• Report Number: 6937282
• 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: Other
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2019
• Device Model Number: 2.25 X 26MM
• Device Catalogue Number: RONYX22526UX
• Device Lot Number: 0008521709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2017
• Distributor Facility Aware Date: 10/02/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 126