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

Catalog Number RONYX27515W

Device Problem Material Distortion (2977)

Patient Problems Intimal Dissection (1333); Angina (1710); Thrombus (2101)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient presented with an acute st-elevated anterolateral wall myocardial infraction.A 2.75 x15 mm resolute onyx drug eluting stent was implanted in a mildly calcified, mildly tortuous, totally occluded lesion exhibiting 100% stenosis in the proximal lad without any reported issue.Device had been inspected with no issues noted.The device did not pass through a previously deployed stent, no resistance was encountered and no excessive force used during delivery.The lesion had been predilated.Intracoronary nitroglycerin and verapamil were administered.Brilinta and aspirin were also administered.There was no abnormality reported in relation to the anatomy.It is reported that the following day the patient presented with chest pain and st elevation; thrombosis was found in the mid-distal stent.The patient was anticoagulated with heparin.An export catheter was used with excellent results; balloon angioplasty was carried out with a 3.0 x 12 nc euphora.No significant dissection was found but there appeared to be dye hang up distal to the stent.A 3 x15 mm resolute onyx was placed in the distal lad and post dilation was carried out using a 3 x12 nc euphora to 24 atmospheres.There was a slight indentation visible in the previously deployed 2.75x15 mm stent.The entire length of the stent was dilated to 25 atmospheres.The physician has commented that ''the reason for the thrombosis is unknown, possible poor anti-platelet effects from brillinta or possible non-visualized dissection although less likely''.It is reported that the patient did well and was discharged.

Manufacturer Narrative

Cine image review: the image of the index procedure captured the total occlusion with 100% stenosis lesion as reported by the account.Pre-dilation and successful stent implantation is visible in the images.The images capture an excellent end results with no restriction noted.Images from the follow up procedure capture the reported thrombosis in the distal end of the previously implanted stent.Ballooning of the thrombosis area was performed, followed by delivery and implantation of the 3.0 x15mm stent.The overlapping stents were then post dilated.The images capture the improved flow post follow up procedure.No dissection is visible on the images provided.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: 7121610
• MDR Text Key: 94980177
• Report Number: 9612164-2017-01974
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169602410
• UDI-Public: 00643169602410
• 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
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2019
• Device Catalogue Number: RONYX27515W
• Device Lot Number: 0008493579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Date Device Manufactured: 02/13/2017
• 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: 64 YR
• Patient Weight: 79