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

Catalog Number 1500300-33

Device Problems Stretched (1601); Device Damaged by Another Device (2915); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem Vascular Dissection (3160)

Event Date 12/04/2018

Event Type  Injury  

Event Description

It was reported through a research article that patient presented with anterior st-elevation myocardial infarction with chest pain.During the percutaneous coronary intervention, a 3.0 x 33 mm xience sierra stent was implanted in the left anterior descending artery (lad), with the proximal stent struts protruding into the ostium of the circumflex artery.Several days later, during a staged procedure to the obtuse marginal (om) artery, a 2.5 x 38 mm xience sierra stent attempted to cross the recently implanted stent in the lad, but resistance was felt, so the 2.5 x 38 mm xience sierra stent system was retracted, but dislodged and was entangled with the lad stent.Both stents became stretched.A snare was used to remove the om stent, but because it was entangled with the lad stent, removal of the om stent resulted in removal of the lad stent and dissections in the lad and distal left main.The arteries were re-wired and new stents were successfully implanted.Results were excellent.Please see article (case 2) for additional information.

Manufacturer Narrative

Date of event estimated.Implant and explant dates estimated the device was not returned for analysis.A review of the lot history record and similar incident query for this product were not performed because the lot number was not reported and the product was not returned for analysis.The reported patient effect of dissection is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the implanted stent interacted with the advancing stent causing the reported difficulty to cross the implanted stent.During retraction continued interaction caused the reported stent stretching, material deformation and complete removal of the implanted stent (explanted) with the patient effect of dissection.The reported treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience sierra device referenced is filed under a separate medwatch report number.Literature attachment.Article title ¿case series of iatrogenic coronary stent avulsion: a rare complication with varied management strategies.¿ (case 2).

• Brand Name: XIENCE SIERRA 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 (P031); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13626132
• MDR Text Key: 287562030
• Report Number: 2024168-2022-02079
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P110019
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500300-33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• 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
• Treatment: 2.5 MM X 38 MM XIENCE SIERRA
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male