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

Catalog Number	1550275-28
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2019
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.H6: device code 2017: re-insertion.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported the procedure was performed to treat a lesion in the heavily calcified proximal left anterior descending coronary artery.Pre-dilatation was performed with an nc trek.The 2.75 x 28 mm xience sierra stent delivery system (sds) was advanced but failed to cross due to the anatomy.The sds was removed without issue.A guide liner and a cutting balloon were used, but both devices became stuck and were removed.The same sds was re-inserted but failed to cross due to the anatomy again.During removal, the sds got stuck in an unspecified guide catheter for a brief moment but was subsequently removed independently.Upon removal, the stent struts were noted to be flared and a big notch was noted on the guide catheter.A new guide catheter and a new xience sierra stent were used to successfully complete the procedure.There were no adverse patient effects 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 evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the difficulties appear to be related to challenging anatomical conditions.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) states: an unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter; however, in this case, it does not appear the instruction for use (ifu) deviation related to re-insertion contributed to the reported difficulties.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 8970371
• Report Number: 2024168-2019-11534
• Device Sequence Number: 10821373
• Product Code: NIQ
• UDI-Device Identifier: 08717648227202
• UDI-Public: 08717648227202
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2020
• Device Catalogue Number: 1550275-28
• Device Lot Number: 9022841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR