MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number RSINT35018UX

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Material Split, Cut or Torn (4008)

Patient Problems High Blood Pressure/ Hypertension (1908); Nausea (1970); Blurred Vision (2137); Dizziness (2194); Chest Tightness/Pressure (2463); Palpitations (2467)

Event Date 04/30/2020

Event Type  Injury  

Event Description

Physician op note: we then pre-dilated both lesions with a 2.5 balloon.We then advanced our 1st stent which was a 4.0 x 38 drug-eluting stent in the more proximal portion.This was deployed to 17 atmospheres.We then attempted to pass a stent distally however, this was a no cross.This was then removed and then we advanced a 3.0 balloon to the more distal portion after double wiring.We then ballooned in there was full expansion of this distal lesion.We then tried to advance the stent again however we noticed that the stent was stripped off the balloon just outside the guide.Notably this was not advance distally however soon as it was out of the guide was stripped off the balloon.We then it attempted several different maneuvers including retrieval with a snare.Wiring through.Wiring next to and then advancing a balloon.This did successfully advanced the stent more into the midportion as opposed to more proximal portion however was unable to retrieve the stent.I consulted with ct surgery and the patient will be referred potential 2 vessel cabg the patient still has a more mid lesion with residual 90%.As well as circumflex lesion.Of note - 1 mo ago while watching tv, he had an episode of blurred vision lasted 5 mins.He followed with cardiology and an event monitor was placed.In the last couple of days, he was told that he would have episodes of a fib.He was advised by cardiology to pass by the office on (b)(6) (tomorrow), and get a prescription for xarelto.On (b)(6) 2020 he was walking / climbing, loading stuff.Attaching/ detaching materials.He can feel his bp raising, he was having palpitations, and his fit bit was registering he had a pulse in the 100s.He felt dizzy nauseated, he had chest pressure.He tried to slow down, tried to relax and breath slow.He was not sure if he was just anxious about what was happening, but his chest pressure was not going away even when at rest.It was about 6/10, he drove himself home.When he got home he called ems, and he was given four bb aspirins and a nitroglycerin sublingual, and his pain resolved.He was brought to the emergency room.His blood pressure was slightly elevated, otherwise his other vital signs are stable.Patient admitted for observation.Fda safety report id # (b)(4).

• Brand Name: RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 10038243
• MDR Text Key: 190501941
• Report Number: MW5094413
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: RSINT35018UX
• Device Lot Number: 0009507339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 142