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

Model Number 1550300-18

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

Patient Problem No Code Available (3191)

Event Date 11/26/2019

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.

Event Description

It was reported that on (b)(6) 2019 the patient presented with non-st elevated myocardial infarction (nstemi) therefore the 3.00x18mm xience sierra was implanted.On (b)(6) 2019 the patient was re-admitted with other cardio vascular symptoms and acute noninfective otitis.It is unknown what treatment was performed and the final patient outcome is unknown.

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.

• 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: 9794258
• MDR Text Key: 182291970
• Report Number: 2024168-2020-02049
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227264
• UDI-Public: 08717648227264
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2020
• Device Model Number: 1550300-18
• Device Catalogue Number: 1550300-18
• Device Lot Number: 9071541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 101