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

Catalog Number RONYX27526UX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Perforation (2001); Rupture (2208); Cardiac Tamponade (2226); Obstruction/Occlusion (2422)

Event Date 10/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Journal article: a cascade of multiple complications hampering a complex high risk percutaneous coronary intervention (chip-pci): when ingenuity overcomes troubles.Journal: wiley year: 2020 ref: doi: 10.1002/ccr3.3446.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A case report in a journal article was submitted titled, a cascade of multiple complications hampering a complex high risk percutaneous coronary intervention (chip-pci): when ingenuity overcomes troubles.The patient underwent a percutaneous intervention to treat a diffusely calcified, chronically occluded vessel in the proximal lad, sub occlusive stenosis in the 1st diagonal branch and a severely narrowed lcx.During the procedure a non-medtronic guidewire was used to cross the lad lesion.The lesion was predilated multiple times using conventional balloons.The non-medtronic guidewire was replaced with another non-medtronic guidewire.Two resolute onyx rx coronary drug eluting stents, 2.5x22mm and 2.75x26mm were implanted overlapping in the mid lad.A 2.0x30mm drug eluting balloon (deb) was used to treat the distal lad.Three resolute onyx des were implanted in the lm/ lad-1st diagonal bifurcation lesions with multiple kissing technique and proximal high-pressure inflations, a 4.0 x22mm onyx, a 3.5x26mm onyx and a 3.0x18mm onyx.At the site of the deb treatment, the distal lad re-occluded.An attempt was made to deliver a 2.25 x 22mm resolute onyx to treat the distal lad, however the stent became trapped in the proximal lm stent.X-ray confirmed that the stent was embedded in the struts of the previously implanted lm stent.The stent dislodged and longitudinal stent deformation was evident.The stent was successfully retrieved using a snare.A telescope guide extension catheter was advanced through the lm bifurcation and a 2.0x22 mm resolute onyx was implanted at nominal pressure in the distal lad.After post dilation, perforations were evident at the site of the distal 2.25x22mm onyx.It was stated that the cause of the perforations was due to the use of the non-medtronic guidewire.The perforations were treated successfully with medication and prolonged balloon inflations.Post procedure, echocardiogram showed a minimal pericardial effusion which was followed by a cardiac tamponade 1 hour later which was treated by pericardial drainage.The patient¿s condition worsened and anterior st elevation with diffuse and severe left ventricular hypokinesis suddenly developed which required vasopressor and the insertion of an intra-aortic balloon pump.Angiography showed a thrombotic occlusion of the lm.The patient received heparin and the thrombus was manually aspirated and kissing balloon inflation and blood flow was restored.There was also a reoccurrence of the pervious leakages.The patient was treated with mechanical hemostasis using a gec and the delivery of a covered stent, which sealed the proximal vessel rupture.Fat harvested from subcutaneous tissue, loaded onto the guidewire between two tips of cut off used balloons and pushed through the catheter using a standard balloon was used to seal the perforation.Permanent hemostasis was achieved and the hemodynamic status recovered.Pre discharge angiography was performed.There was no evidence of thrombosis or further leakages.

Manufacturer Narrative

Additional information: patient's weight.There was no damage evident to the previously implanted 4.0 x22mm resolute onyx stent after the 2.25 x 22mm resolute onyx was trapped in it.A 2.0 x 30 mm in.Pact falcon drug eluting balloon (deb) was used to treat the distal lad.It was further stated that the 2.25 x 22 mm resolute onyx device was inspected before use with no issues.The 2.25 x 22 mm resolute onyx device was prepped per ifu with no issues.The lesion was pre-dilated.Resistance was not noted distally, a telescope system was advanced to avoid further problems through stents previously implanted.Excessive force was not used.Resistance was not noted during the withdrawal of the 2.25 x 22 mm onyx device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11284527
• MDR Text Key: 230426996
• Report Number: 9612164-2021-00521
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RONYX27526UX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 55