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

Model Number	1550300-12
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device is not returning.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 the procedure was to treat a heavily calcified lesion in the moderately tortuous left anterior descending (lad) coronary artery.A rotablator was used and balloon angioplasty was performed.The 3.00x12 mm xience sierra stent delivery system (sds) failed to cross so pre-dilatation was performed with a cutting balloon.The xience sierra sds was reinserted and the stent was implanted at 16 atmospheres.Upon removal, blood was noted inside the balloon, indicating a rupture.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 identified no similar incidents from this lot.It was reported that the device was reinserted into the patient.It should be noted that the xience sierra, everolimus eluting coronary stent system, instructions for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodge during retraction back into the guiding catheter.It is unknown if the ifu deviation directly caused or contributed to the reported event.The investigation determined the reported difficult to advance and material rupture appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10284928
• Report Number: 2024168-2020-05900
• Device Sequence Number: 2679002
• Product Code: NIQ
• UDI-Device Identifier: 08717648227240
• UDI-Public: 08717648227240
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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 Expiration Date: 09/10/2021
• Device Model Number: 1550300-12
• Device Catalogue Number: 1550300-12
• Device Lot Number: 808304A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1