MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING

Catalog Number RSINT22518JX

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombus (2101)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Two resolute integrity drug eluting stents to treat two lesions during an emergency case.The first de novo lesion was located in the lad and was reported to have 90% stenosis (bifurcation lesion).The second de novo lesion was located in the left main trunk and was reported to have 75% stenosis (bifurcation lesion of the left main trunk).There were no abnormalities reported in relation to anatomy.Both devices were inspected prior to use.Both lesions were pre-dilated.The device did not pass through a previously-deployed stent.There was no resistance and no excessive force used.The first resolute integrity stent was deployed in the lad using inflation pressure of 8 atm/10 sec in distal and 8 atm/15 sec in medial.The second resolute integrity stent was deployed in the left main trunk using an inflation pressure of 7 atm/35 sec in distal, 15 atm/15 sec in medial and 15 atm/15 sec in proximal.The first lesion was not post dilated due to the narrow vessel diameter but the second lesion was.The lmt lesion was located at the bifurcation to hl (high lateral) and lcx (left circumflex artery), and therefore fenestration was performed after stent implantation.Initially after implantation no issues or injuries were reported with timi 3 flow before and after the procedure and post operative stenosis was 0%.Aspirin and clopidogrel were initiated at the time of index procedure, clopidogrel was discontinued after 1 year post implant.Approximately thirty one months post procedure it was reported that the patient developed persistent chest and upper back pain, and on the following day, electrocardiogram showed obvious elevation and depression of st-segment, for which cag was performed.At the proximal edge of the stent in the lad, a radiolucent shadow that appeared to be thrombosis was observed (very late thrombosis).After thrombus aspiration, ivus showed that a part of the stent had insufficient expansion, thus poba was performed using a 2.5mm balloon.After that, the patient has continued dapt (dual antiplatelet therapy).Other medication included amlodipine and lipitor.It is unknown whether there is resistance or durability against the prescribed antiplatelet drugs.Cine images are not available.The patient is in remission.Physician¿s comment -the patient presented loss of appetite as a cold symptom and slightly dehydrated.

Manufacturer Narrative

Additional information: both lesions exhibited mild tortuosity and eccentric calcification, the lesion was located at the bifurcation to the diagonal branch.It was noted that the resolute integrity 2.25*18mm failed to expand fully.The previously reported st-elevation myocardial infarction occurred approximately 31 months post the procedure.The physician stated that it could not be denied that the insufficient stent expansion possibly contributed to the thrombus.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6897760
• MDR Text Key: 87517551
• Report Number: 9612164-2017-01326
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Catalogue Number: RSINT22518JX
• Device Lot Number: 0007170077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Date Device Manufactured: 05/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 57