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

Catalog Number UNK RX SIERRA

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

Patient Problem Occlusion (1984)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated procedure date.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Implant date: estimated implant date.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effect of occlusion is listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a lesion in an unspecified vessel.The xience sierra stent was implanted, jailing a side branch.The side branch was re-wired and a dilatation catheter balloon was inflated, re-opening the vessel.Post procedure, the patient was is stable condition.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9843150
• MDR Text Key: 186759268
• Report Number: 2024168-2020-02548
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX SIERRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention