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

Catalog Number 1550225-08

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

Patient Problem Prolapse (2475)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4)-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 stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2019, a 2.25x8mm xience sierra stent was implanted in the proximal circumflex (cx) lesion without a device deficiency.During stent deployment, a plaque shift occurred from the proximal cx to the proximal left anterior descending (lad) coronary artery.Balloon angioplasty was performed as treatment and the event resolved.The patient was discharged from the hospital that same day.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(s) of prolapse is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears 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.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.

• 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: 8860243
• MDR Text Key: 153246601
• Report Number: 2024168-2019-10572
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648226991
• UDI-Public: 08717648226991
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2020
• Device Catalogue Number: 1550225-08
• Device Lot Number: 9032841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 81