MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; 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 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: date is estimated.The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported as a general comment that the physician feels that the xience sierra stent delivery system has poor visibility under the x-ray.Therefore, the physician prefers a non-abbott stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot 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).There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The udi is unknown because the part and lot #s were not provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10292428
• MDR Text Key: 199520734
• Report Number: 2024168-2020-05960
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• 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: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1