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

Model Number	1550325-33
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted due to no reported lot number reported.It should be noted that the xience sierra everolimus eluting coronary stent system instructions for use (ifu) states: note the ¿use by¿ (expiration) date specified on the product label.The investigation determined the reported difficulties appear to be related to deviation of the instructions for use as the device was inadvertently used past the expiration date.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that a 3.25x33mm xience sierra stent delivery system (sds) was advanced in the patient anatomy; however, it was noted that the product was expired therefore the sds was removed and the stent was not deployed.The procedure was successfully completed with a new 3.25x33mm xience sierra stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: RX SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10106938
• Report Number: 2024168-2020-04656
• Device Sequence Number: 14277283
• Product Code: NIQ
• UDI-Device Identifier: 08717648227370
• UDI-Public: 08717648227370
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1550325-33
• Device Catalogue Number: 1550325-33
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1