MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX OTW; STENT, CORONARY, DRUG-ELUTING

Catalog Number RONYX22526W

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Myocardial Infarction (1969); Occlusion (1984); Thrombus (2101)

Event Date 10/21/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician used four resolute onyx otw coronary drug eluting stent to treat a mildly tortuous and calcified lesion located in the proximal left anterior descending artery, exhibiting 100% stenosis.Artery diameter 2.5 mm and artery length 24 mm.The 2.5 x 18 stent was deployed at 18 atm for 8 seconds and post dilated 3 times in the distal of the proximal lad.The 2.25 x 26 was deployed at 18 atm for 8 seconds and post dilated 4 times.The 2.25 x 26 stent was deployed at 18 atm for 10 seconds and post dilated 5 times, 20 atm for 8 seconds and 6 times 20 atm for 6 seconds.The 2.25 x 26 stents were conformed to be distal to the 2.5 x 18 however, as the patient had chest pain he was moving around, the stents were seen to be proximal to the first.During angiography, post procedure, the stent had moved proximally in the lad.The 2.25 x 15 was deployed at 12 atm for 8 seconds and post dilated 7 at 18 atm for 6 seconds.There were no abnormalities reported in relation to anatomy.There was no damage noted to the device packaging, and no issues noted when removing the device from the hoop/tray.The devices were inspected with no issues identified.Negative prep was not performed.The lesion was pre-dilated.The devices did not pass through a previously-deployed stent.Resistance was not encountered when advancing the devices, however placement issues were noted.Excessive force was not used during delivery.The patient was discharged on brilinta <(>&<)> aspirin.Approximately 6 days later the patient presented with st elevated myocardial infarction secondary to acute stent thrombosis.Coronary angiography revealed total occlusion of the stents at the first septal perforator branch.Thrombus was treated with a bolus of integrillin and heparin followed by balloon dilatation.Intracoronary nitroglycerin and verapamil were administered.Multiple views were then obtained which appeared to exhibit patency of the stents.Approximately 2 weeks later the patient presented with chest pain and had ekg suggestive of acute st-elevation anterior wall mi and stent thrombosis.The lad exhibited a proximal 100% stenosis.Balloon dilatation was carried out in the mid, proximal and distal lad.Ivus was done and it was reported that the stent was malapposed in the proximal lad.Post-dilatation using a 3.0 nc balloon was carried out.Ivus was done again and it was noted that the stent in the proximal lad was well-apposed.Post procedure stenosis was 0%.Patient status post-procedure is alive with no injury.No relevant patient medical history present that may have made the patient more prone to a thrombolytic event.

Manufacturer Narrative

Cine image review index procedure: the vessel is neither mildly tortuous and nor calcified.The images show the stent treatment from proximal to distal.Not all the lesion was pre-dilated, only the proximal part at the beginning of the procedure.A total prox-lad occlusion (timi flow 0) is observed due to acute thrombus, timi flow 2 is recovered after poba.A proximal stent is implanted, although it is noticed the diffuse disease up to mid-lad.A second stent is implanted within with the first one, then subsequently two more stents are implanted from proximal to distal part of the vessel.All lesions were finally covered and timi flow 3 recovered.6 days post index prox-lad stent thrombosis is observed, timi flow is recovered after multiple pobas.Final poba is performed at the lad origin with a smaller balloon.21 days post index prox-lad stent thrombosis is observed, timi flow recovered after poba, ivus is notice.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The first implanted 2.25 x 26 stent was confirmed to be distal to the 2.5 x 18 however as the patient had chest pain he was moving around the stent was seen to be proximal to the first.The second implanted 2.25 x 26 stent was confirmed to be distal to the 2.5 x 18.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX OTW
• 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: 7112082
• MDR Text Key: 94638928
• Report Number: 9612164-2017-01908
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169602267
• UDI-Public: 00643169602267
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2019
• Device Catalogue Number: RONYX22526W
• Device Lot Number: 0008497683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2018
• Date Device Manufactured: 02/15/2017
• 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: 58 YR
• Patient Weight: 91