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

Catalog Number	1550350-33
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	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code 2017- improper or incorrect procedure or treatment - excessive force.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 device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a mildly calcified, heavily tortuous right coronary artery.The 3.50x33mm rx xience sierra stent delivery system (sds) failed to cross the lesion due to the anatomy.During withdrawal, the sds caught the edge of an unspecified guiding catheter.With force, the sds was removed from the anatomy independently from the guiding catheter.Outside of the anatomy it was noted that the stent struts were mangled and lifted off the balloon.A new 3.25x33 xience sierra sds was 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 analysis.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 did not indicate a lot specific quality issue.The sierra everolimus eluting coronary stent system (eecss), instructions for use (ifu) states: after successful withdrawal of the balloon from the deployed stent, should any resistance be felt at any time when withdrawing the stent delivery system or post dilatation balloon into the guide catheter, remove the entire system as a single unit.Failure to follow these steps and / or applying excessive force to the delivery system can potentially result in loss or damage to the stent and / or delivery system components.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the difficult anatomy during advancement to the lesion causing the reported failure to advance.The device was then removed but was not coaxially aligned with the guiding catheter during removal causing the reported interaction between the device and the guiding catheter (difficulty to remove) and subsequent material deformation.There is no indication of a product quality issue with respect to manufacture, design or labeling.Contact office first and last name was updated from (b)(6) to (b)(6).
Event or Problem Description
It was reported that the procedure was performed to treat a mildly calcified, heavily tortuous right coronary artery.The 3.50x33mm rx xience sierra stent delivery system (sds) failed to cross the lesion due to the anatomy.During withdrawal, the sds caught the edge of an unspecified guiding catheter.With force, the sds was removed from the anatomy independently from the guiding catheter.Outside of the anatomy it was noted that the stent struts were mangled and lifted off the balloon.A new 3.25x33 xience sierra sds was 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.

• 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: 8883965
• Report Number: 2024168-2019-10759
• Device Sequence Number: 2499260
• Product Code: NIQ
• UDI-Device Identifier: 08717648227455
• UDI-Public: 08717648227455
• 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 an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2019
• Device Catalogue Number: 1550350-33
• Device Lot Number: 8100441
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 08/12/2019
• 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