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

Catalog Number 1500250-33

Device Problems Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The first 2.5x18 xience sierra is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a de novo lesion in a heavily calcified and moderately tortuous proximal left anterior descending artery.A 2.5 x 33 mm xience sierra stent was implanted in the left main.Post-dilatation was performed with a 2.5 non-abbott balloon catheter, and an attempt was made to advance a 2.5 x 18 mm xience sierra stent delivery system (sds).However, it met resistance with the anatomy at the bifurcation.Therefore, an attempt was made to remove the sds, and it became caught with the implanted 2.5 x 33 mm xience sierra stent.Force was then applied and both stents became dislodged and were floating in the aorta.Therefore, a snare device was used to remove both stents and no foreign material was left in the patient.Another 2.5 x 33 mm and a 2.5 x 18 mm xience sierra stent were implanted to successfully complete the procedure.Reportedly, the first two xience sierra devices used were not prepped prior to removing the protective sheath/stylet removal.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was returned for analysis.The reported device damaged by another (explanted) was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.It was reported the xience sierra was prepped prior to sheath removal.It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use lists packaging removal (sheath removal) to be performed prior to system preparation.In this case, it does not appear the instruction for use (ifu) deviation related to prepping the sds prior to sheath removal contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Additionally, post dilation was performed after successful deployment of the stent per instructions for use.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8972305
• MDR Text Key: 156884341
• Report Number: 2024168-2019-11562
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2022
• Device Catalogue Number: 1500250-33
• Device Lot Number: 9031341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2.5X18MM XIENCE SIERRA
• Patient Outcome(s): Required Intervention