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

Catalog Number 1500350-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Prolapse (2475)

Event Date 04/16/2020

Event Type  Injury  

Manufacturer Narrative

The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional xience sierra device referenced is filed under a separate medwatch report number.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2020, a percutaneous coronary intervention (pci) was performed on the mid right coronary artery (rca), 70% stenosed lesion.A 3.5x23mm (1500350-23, 9110141) xience sierra stent was implanted distally in the mid rca and a 3.5x18mm (1500350-18, 0012041) xience sierra stent was implanted more proximal in the mid rca.Post-implantation, distal plaque shift occurred within the distal, 3.5x23mm xience sierra stent, along with a non-significant proximal dissection with the 3.5x18mm xience sierra stent.The 3.5x18mm xience sierra was also observed with proximal stent malapposition.Based on the post-stent findings, balloon angioplasty and another stent, a 3.5x12mm (1500350-12, 0011341) xience sierra stent was implanted without an issue reported.Reportedly, the dissection required no treatment.The event resolved without sequela.Timi flow 3 with 0% diameter stenosis was observed and the procedure results were deemed acceptable.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the reported patient effect of prolapse is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• MDR Report Key: 10049480
• MDR Text Key: 190754972
• Report Number: 2024168-2020-04257
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2022
• Device Catalogue Number: 1500350-23
• Device Lot Number: 9110141
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XIENCE SIERRA STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 76