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

Model Number 1550225-28

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem Perforation (2001)

Event Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodge during retraction back into the guiding catheter.The reported patient effect of perforation is listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported failure to advance and subsequent treatment appear to be related to the operational context of the procedure.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a mildly calcified, mildly tortuous, de novo mid ramus that was 100% stenosed.Pre-dilatation was done with a 1.2x12mm trek balloon, a 2x15mm trek balloon, and a 2.5x15mm trek balloon.The 2.25x28mm xience sierra stent delivery system (sds) was advanced using a guiding catheter but failed to cross due to the anatomy.Using a new guide support catheter, a second attempt was made to cross but failed again due to the anatomy.A perforation was then observed.Additional dilatation was done and the sds was reattempted but did not cross.The xience sierra sds was replaced with a 2.25x26mm non-abbott sds.The replacement device crossed immediately and was deployed.Post-dilatation was done with long inflations to successfully treat the perforation.There was no adverse patient sequela reported.No additional information was provided.

• 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: 11156581
• MDR Text Key: 226326245
• Report Number: 2024168-2021-00351
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227042
• UDI-Public: 08717648227042
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2021

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 Expiration Date: 05/26/2021
• Device Model Number: 1550225-28
• Device Catalogue Number: 1550225-28
• Device Lot Number: 0052141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEZILLA GUIDELINER
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 88