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

Catalog Number UNK RX SIERRA

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: estimated date of event.The customer reported the device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.

Event Description

It was reported in a general comment made by the physician that there is poor visibility of the xience sierra stents under fluoroscopy and non-abbott stents have been favored.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.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.The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The investigation was unable to determine a conclusive cause for the reported difficulty positioning (poor visibility during fluoroscopy); however, factors that may contribute to difficult positioning include, but are not limited to, material issues, incorrect contrast mix and incorrect device preparation.Additionally, it should be noted that this observation was presented during a general conversation and is not related to a specific event and/or 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: 8822990
• MDR Text Key: 152084743
• Report Number: 2024168-2019-10308
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX SIERRA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1