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

Catalog Number	1550400-15
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	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G9: 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 stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that after implanting the xience sierra stent on (b)(6) 2019, it was noted to be expired.The patient is doing well.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
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.Reportedly, after implanting the xience sierra stent, it was noted to be expired.It should be noted that the xience alpine everolimus eluting coronary stent system instructions for use, states: do not use after the use by date.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported device expiration issue appears to be related to the use error.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: XIENCE 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: 9396036
• Report Number: 2024168-2019-14008
• Device Sequence Number: 19530635
• Product Code: NIQ
• UDI-Device Identifier: 08717648227493
• UDI-Public: 08717648227493
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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 Expiration Date: 10/21/2019
• Device Catalogue Number: 1550400-15
• Device Lot Number: 8101541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 100