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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY SYSTEM CORONARY DRUG-ELUTING STENT Back to Search Results
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).
 
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Brand NameRESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY SYSTEM
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC IRELAND
MDR Report Key10038243
MDR Text Key190501941
Report NumberMW5094413
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received05/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2021
Device Model NumberRSINT35018UX
Device Lot Number0009507339
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 05/07/2020 Patient Sequence Number: 1
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