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

Catalog Number UNK RX SIERRA

Device Problems Break (1069); Material Separation (1562)

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2022

Event Type  Injury  

Manufacturer Narrative

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 date of event is estimated to (b)(6) 2021.The date of implant is estimated to (b)(6) 2021.

Event Description

It was reported that the unspecified implanted xience sierra stent fractured.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

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 device referenced in b5 is/are filed under separate medwatch report number.A2, a3, a4: updated b1: updated from product problem to product problem and adverse event b2: updated from ni to required intervention and hospitalization-initial or prolonged b3: date updated b5, b6, b7: updated d6a: date updated section e1: updated h1: updated from malfunction to serious injury h6: codes 4582, 2199, 1069 removed and codes 4641, 1969, 4440, 4607 and 1562 added.

Event Description

Subsequently, after the initial was filed it was confirmed the procedure was to treat a right coronary artery (rca).Two unspecified xience stents were implanted on (b)(6) 2021 without issue.On (b)(6) 2022, the patient present with st elevation myocardial infarction (stemi) with thrombosis in the mid rca.The xience sierra stent implanted in the mid rca was noted to be completely fractured.A second xience sierra stent in the distal posterior atrioventricular (pav) segment was noted to be partially fractured.Additional stents were placed.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the electronic lot history record (elhr) 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.It is possible that fatigue from cardiac dynamics and motion after the procedure resulted in the reported cracked/fractured stent; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Additionally, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The reported patient effects of thrombosis and myocardial infarction are listed in the xience sierra everolimus eluting coronary stent system instructions for use as adverse events associated with use of this device.The treatment(s) 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.B5 - describe event or problem: updatedna.

Manufacturer Narrative

Provided media include angiograms from 2021 which were reviewed by an abbott clinical specialist which shows successful stent implantation of the right coronary artery (rca), no stent fractures are observed in this media.The provided media also includes angiograms from 2022 in which a stent fracture is observed in the mid-rca.While the provided media confirm the complaint summary description a probable cause of the stent fracture cannot be determined.H10: the cine review was not captured on the mdr filed on 05/18/2023.

• 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 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15946431
• MDR Text Key: 305593580
• Report Number: 2024168-2022-12432
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX SIERRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 66 KG