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

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

Patient Problems Myocardial Infarction (1969); Occlusion (1984); Perforation (2001); Thrombus (2101); Injury (2348); Vascular Dissection (3160)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: risk of dislodgement of ultrathin drug eluting stents versus thick drug eluting stents ref: doi.Org/10.1016/j.Amjcard.2020.03.005.Average age, majority gender, date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted that documented a study "risk of dislodgement of ultrathin drug eluting stents versus thick drug eluting stents" which retrospectively analysed and compared the incidence and outcomes of stent dislodgment in thick (tss) and ultrathin strut stents (uss).Resolute onyx coronary rx des, resolute integrity coronary rx des and resolute endeavor coronary rx des were among a number of non- medtronic des stents used during pci procedures.The data of 8,564 consecutive patients who underwent percutaneous coronary intervention with des implantation in the same institution between 1st january 2005 to 1st january 2020 was retrospectively analysed.During pci, patients were anticoagulated with unfractionated heparin.Predilatation was usually performed with semicompliant or even noncompliant balloon and using rotational atherectomy.Stent dislodgments was reported for both groups and were classified as: 1) partial stent dislodgment when the stent is detached from the balloon before reaching the target lesion but is still over the shaft of the delivery balloon; 2) complete stent loss in the coronary tree before reaching the target lesion; and 3) complete stent loss into the vascular tree.Treatments of stent dislodgment included; leaving the stent into the coronary vessel and crushing with another stent; retrieving of the stent with snare; and parking the stent into a peripheral vessel.Independent predictors of stent dislodgement in the patient population were; cto, bifurcation lesion, coronary calcification, ostial lesion, tortuosity and lesion length =25 mm clinical outcomes reported to be related to stent dislodgement included acute intraprocedural and periprocedural vessel dissection, abrupt closure, coronary perforation, stent thrombosis, acute target-vessel myocardial infarction.Clinical outcomes at 12 month follow-up included 2 cardiac deaths, acute target-vessel myocardial infarction, stent thrombosis and target lesion revascularization.It was noted that the two cases of stent thrombosis discovered at 12 month follow-up occurred at the site of previous dislodged stent (both patients with previously crushed stents).Patient co morbidities included: obesity, hypertension, diabetes mellitus, dyslipidaemia, previous acute myocardial in infarction, p revious coronary artery bypass graft and previous percutaneous coronary intervention.It was subsequently reported that there was no causal relationship between the medtronic devices and the cardiac deaths reported.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10261875
• MDR Text Key: 198712796
• Report Number: 9612164-2020-02535
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• 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