MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number UNK XIENCE

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

B3,d6a- date of event, implant date are estimated dates.D4- the udi number is not known as the catalogue number was not provided.The devices were not returned for analysis.A review of the electronic lot history record and similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported malposition of the device; however, factors that may contribute malposition include but are not limited to incorrect device size for lesion, patient anatomical morphology, and patient disease state.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional patient effects and/or malfunctions reported in the article are captured under separate medwatch reports.Literature attachment: article titled: "expansion of stents after intravascular lithotripsy versus conventional predilatation in calcified coronary arteries.".

Event Description

This study was aimed to investigate if pre-treatment with intravascular lithotripsy (ivl) in severely calcified lesions increases stent expansion, assessed by optical coherence tomography (oct), when compared to pre-dilatation with conventional and/or specialty balloon strategy.Exit-calc (expansion of stents after intravascular lithotripsy versus conventional predilatation in calcified coronary arteries) was a prospective, single-center, randomized controlled study.Patients with an indication for percutaneous coronary intervention(pci) and severe calcification of the target lesion were allocated to pre-dilatation with conventional angioplasty balloons or pre-treatment with ivl, followed by drug-eluting stenting and mandatory post-dilatation.Primary endpoint was stent expansion assessed by oct.Secondary endpoints were the occurrence of peri-procedural events and major adverse cardiac events (mace) in hospital and during follow-up.Oct was performed using the oct ilumien system and optis imaging catheters.The pullbacks or frames with poor image quality were excluded.It was also noted that the imaging catheter would not pass the lesion in the right circumflex (rcx) due to angulation and severe calcification.Oct was performed subsequent to implanting xience drug-eluting stents.Assessment of possible peri-procedural infarction was performed when clinically indicated the following major adverse cardiac events (mace) at 30-days, 2-year, and 3-year follow-up: cardiac death, myocardial infarction, target lesion revascularization [surgery], and stent thrombosis.Other oct characteristics such as malposition, edge dissection, tissue damage were scored.There were no additional stents implanted to treat the stent edge dissection.There were 2 postprocedural bleedings in the forearm, both in the ivl group, which were resolved without complications using pressure bandages.The mace results indicate prolonged hospitalization.In the prospective, randomized exit-calc study we found no significant difference in minimal stent expansion after plaque modification using ivl or conventional pre-dilatation, in patients with prespecified severe coronary artery disease assessed by oct.Ivl was safe as no periprocedural complications occurred.Specific patient information is documented as unknown.Details are listed in the attached article, titled "expansion of stents after intravascular lithotripsy versus conventional predilatation in calcified coronary arteries." no additional information was provided.

• Brand Name: XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17365488
• MDR Text Key: 320230363
• Report Number: 2024168-2023-07792
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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