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

Catalog Number 1500300-23

Device Problems Stretched (1601); Device Damaged by Another Device (2915); Material Deformation (2976); Migration (4003)

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

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated: the unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant: estimated.The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.In this case, it is likely the guidewire became entrapped while deploying the 3.00x23 xience sierra, in an attempt to overlap a previously implanted stent.Force was applied while attempting to remove the guidewire, causing the reported device damaged by another device, stretching the stent, contributing to the reported material deformation, ultimately causing the stent to migrate from the original implantation location.The separated portion of the wire was able to be snared and removed.The investigation determined the reported difficulties and the subsequent treatment appear 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.The versaturn guide wire device is filed under a separate medwatch report number.Attached article titled ¿case series of iatrogenic coronary stent avulsion: a rare complication with varied management strategies.¿ (case 1).

Event Description

It was reported that the patient presented with non-st-elevation acute coronary syndrome (nsteacs).Percutaneous coronary intervention (pci) using optical coherence tomography (oct) revealed that a previously implanted stent in the proximal circumflex (cx) artery was severely restenosed.The lesion was wired with a versaturn guide wire.After lesion preparation with a scoring balloon, a 3.0x23mm xience sierra stent was implanted without difficulty, overlapping the previously implanted stent; however, the wire became entrapped in the stent.Attempts were made to free the wire, but were unsuccessful.Forceful retraction of the wire resulted in the wire separating into two pieces and the stent being stretched, deformed and possibly moved from the original site of implant, but remains in the lesion.The separated portion of the wire was able to be snared and removed.Another xience sierra stent was implanted.Two additional xience sierra stents were implanted and the stent post dilated, fully expanding the stretched stent to fully appose the vessel wall.The patient was discharged on dual antiplatelet therapy.The patient was followed for 24 months with no recurrence of symptoms.Details are listed in the attached article titled ¿case series of iatrogenic coronary stent avulsion: a rare complication with varied management strategies.¿ (case 1) please see article for additional information.

• 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: 13664159
• MDR Text Key: 287116680
• Report Number: 2024168-2022-02213
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500300-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/03/2022
• 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: UNK HT VERSATURN
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male