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

Model Number	1550350-12
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was performed to treat a spontaneous coronary artery dissection (scad) in the circumflex (cx) artery.Two unknown stents were implanted first, a 3.0x38 mm stent in the distal cx and a 3.5x38 in the proximal cx.The 3.5x12 mm sierra stent delivery system (sds) was to be implanted in the gap between the two stents.But the sierra sds failed to cross through the 3.5x38 stent.Resistance was felt during removal and the stent dislodged from the balloon.Attempts to retrieve the stent were unsuccessful.The stent is free-floating in the left posterior descending artery.There was no injury and no clinically significant delay during the procedure.The patient is stable.There was no damage to the previously implanted stent.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.A conclusive cause for the reported difficulties cannot be determined; however, the subsequent treatments appear to be related to the operational context of the procedure.It was reported that a xience sierra stent delivery system (sds) was attempted to be advanced in-between two previously implanted stents.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use states: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obviates the need to cross the proximal stent during placement of the distal stent and reduces the chance of damaging or dislodging the proximal stent.It is unknown if the ifu deviation(s) directly caused or contributed to the reported event.There is no indication of a product quality issue with respect to manufacture, design or labeling.(b)(4).

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: 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: 14142260
• Report Number: 2024168-2022-04190
• Device Sequence Number: 15016149
• Product Code: NIQ
• UDI-Device Identifier: 08717648227400
• UDI-Public: 08717648227400
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2022
• Device Model Number: 1550350-12
• Device Catalogue Number: 1550350-12
• Device Lot Number: 0101441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANTED STENTS (X2)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female