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

Model Number RSINT40022X

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)

Patient Problems Angina (1710); Stenosis (2263); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 04/06/2023

Event Type  Injury  

Manufacturer Narrative

Title: coronary stent off-wire dislodgement: case report of a rare complication".Authors: meng-ying lu, kuang-te wang.Journal name: the texas heart institute journal, year: 2023 , reference: https://doi.Org/10.14503/thij-20-7505, b3: date of publication.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.

Event Description

A journal article was submitted for review titled "coronary stent off-wire dislodgement: case report of a rare complication".This case report describes a patient with an off-wire coronary stent dislodgement that resulted in the proximal end of the stent being stuck in the left main coronary artery (lmca) and the stent tail floating in the aorta.The patient had underwent a percutaneous coronary intervention (pci) 14 years prior during which a 3.0 × 18mm endeavor resolute drug eluting stent was placed in the proximal left anterior descending coronary artery (lad).Ten years later, the patient underwent pci and had a 4.0 × 22mm resolute integrity drug eluting stent placed from the proximal left circumflex artery (lcx) into the proximal left main coronary artery (lmca).During a recent admission to the cardiovascular ward for unstable angina, a diagnostic coronary angiography was performed via the left radial artery and revealed a long, diffuse lesion with 80% to 95% stenosis extending from the proximal to the middle lad and a lesion with90% stenosis in the proximal right coronary artery (rca).The first pci to treat the rca lesion was performed without any complications.Then, a second pci was performed to treat the lad lesion.A 6f extra backup (ebu) 3.5 guiding catheter was used to smoothly deliver the non mdt guidewire into the distal lad.After performing plain old balloon angioplasty using a non mdt 3.25 × 15-mm non-compliant balloon from the side-branch cell of the lmca-lcx stent to the middle portion of the lad, a 3.5 × 33-mm non mdt sirolimus-eluting stent was introduced into the lad.However, the stent could not be delivered to the target lesion despite multiple attempts at distal advancement.Fluoroscopy revealed that the stent tip was stuck in the lmca.During an attempt to retract the new stent into the guiding catheter with forceful maneuvering, the stent became detached from the stent balloon and guidewire.The proximal elongated segment of the stent was attached to the lmca, and the distal segment was floating in the aorta.To prevent thrombosis, an attempt was made to retrieve the floating segment using a 7-mm amplatz goose neck microsnare, but multiple attempts were unsuccessful.The floating stent segment was waving rhythmically with the patient¿s heartbeat and breathing cycle, making approach with the gooseneck microsnare difficult.After this conventional retrieval method failed, the decision was made to try an non mdt vascular snare kit, which is typically used to retrieve a dislodged catheter or guidewire in the peripheral vasculature.The snare¿s 6f delivery catheter was advanced through the 6f ebu guiding catheter without resistance and the 15° angled tip on the catheter enabled an easier approach to the floating stent.The stent was successfully retrieved without any angiographically obvious injury.Although the bulk of the stent was retrieved, a fragment of the broken string remained adherent to the lmca.After performing plain old balloon angioplasty with a 2.0 × 15-mm non mdt non compliant balloon from the proximal lad to the lmca, the lesions from the middle lad to the lmca were assessed using intravascular ultrasonography (ivus).This examination revealed a stent malapposition in the middle lmca.The ostial lad was stent free, indicating that the proximal edge of the stent was located at the proximal segment of the lad and was not involved in the stent entrapment.Because there was a type b dissection in the middle lad, a 3.0 × 38mm non mdt sirolimus-eluting stent was positioned and deployed via a 5.5f non mdt guide extension catheter.Dilation with a 3.25 × 15mm non mdt non-compliant balloon was performed for proper stent apposition.On re-examination, ivus showed a lump of metal that resembled the crushed stent strut.Finally, a 4.0 × 15mm non mdt sirolimus-eluting stent was deployed from the proximal lad to the ostial lmca, with a satisfactory angiographic result.The patient remained event free for more than 1 year during outpatient follow-up.The mechanism of stent entrapment in the lmca could not be determined because of the limited ivus image resolution.It was believed that there were 2 possible mechanisms: either the original stent became entrapped at the side-branch cell of the lmca-lcx stent during delivery, or it became entrapped at the proximal edge of the lmca-lcx stent in the lmca because of malapposition.

Manufacturer Narrative

Additional information: annex d code.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.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17257479
• MDR Text Key: 318451131
• Report Number: 9612164-2023-02992
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSINT40022X
• Device Catalogue Number: RSINT40022X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 08/11/2023
• 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: 73 YR
• Patient Sex: Male