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

Catalog Number 1500250-28

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

Patient Problems Angina (1710); Thrombosis/Thrombus (4440)

Event Date 11/27/2019

Event Type  Injury  

Event Description

This event was identified through review of an article stating in the case study the subject is a (b)(6) male whom presented with a st-segment elevation myocardial infarction.A coronary angiography revealed severe stenosis in the obtuse marginal branch (om) and sub-total occlusion of the posterolateral artery (pl).The lesions were treated with a 2.5x33mm and a 2.5x28mm xience sierra stents.Dual antiplatelet therapy was initiated with a loading dose before the primary percutaneous coronary intervention (pci) followed by maintained dose.Five days later, the patient experienced chest pain.After wiring into the om and pl the lesion was evaluated with a dragonfly optical coherence tomography (oct) imaging catheter.The oct imaging catheter revealed thrombus within both the om and pl stents.After deployment of a distal protection filter device at the pl branch, balloon angioplasty was performed several times by a 2.5x15mm non-compliant balloon.Coronary angioscopy and oct revealed an ulcer lesion and floating thrombus at the main branch of the left circumflex (lcx) and protrusion of the om stent struts to the branch of the lcx.Although the floating thrombus was observed during the index procedure, it occurred prior to implantation of the two xience sierra but was not treated because it did not limit the coronary flow.The floating thrombus and ulcer lesion were treated with a 4.0x8mm xience sierra stent followed by a kissing balloon technique between the main branch of the lcx and the om.It was confirmed that the floating thrombus was fully covered by the stent with oct.During hospitalization, the patient underwent a pci to the left anterior descending artery.At the 9-month follow-up the patient was free of symptoms.Specific patient information is documented as unknown.Details are listed in the article, titled "synergistic mechanism of coincidence of two subacute stent thromboses: insights from multiple imaging observations".

Manufacturer Narrative

Date of event is estimated.Date of implant is estimated.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional xience sierra referenced is being filed under a separate medwatch report number.Literature: article title "synergistic mechanism of coincidence of two subacute stent thromboses: insights from multiple imaging observations".

Manufacturer Narrative

The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the lot number was not reported and the product was not returned for analysis.The reported patient effects of angina and thrombosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.B3: date of event updated from (b)(6) 2020 to (b)(6) 2019.D6: date of implant updated from (b)(6) 2020 to (b)(6) 2019.G2: report source was updated to add health professional and company representative.

• 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: 13011447
• MDR Text Key: 282283930
• Report Number: 2024168-2021-11626
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1500250-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• 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: 2.5X33MM XIENCE SIERRA
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male