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

Catalog Number 1550350-12

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

Patient Problems No Information (3190); No Code Available (3191)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).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

It was reported that on (b)(6) 2019, a 3.25x08, 3.50x12mm, 3.50x23mm xience sierra stents were implanted without reported issues.On (b)(6) 2019, the patient was re-admitted to the hospital for atherosclerotic heart disease and other cardiovascular symptoms.Unspecified treatment was provided.No coronary imaging was reported and there was no additional percutaneous coronary intervention performed.The patient has been discharged home.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.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.Patient code 3190 removed.

• 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: 8956875
• MDR Text Key: 156350235
• Report Number: 2024168-2019-11382
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227318
• UDI-Public: 08717648227318
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2020
• Device Catalogue Number: 1550350-12
• Device Lot Number: 9011741
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 XIENCE SIERRA STENTS; XIENCE SIERRA STENT X2; XIENCE SIERRA STENT X2
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Weight: 63