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

Model Number	1550250-38
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.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 performed to treat a non-calcified, non-tortuous left anterior descending artery.The 2.50x38mm xience sierra stent delivery system was prepared and advanced without issue.During inflation, the balloon ruptured at 4atm.The physician realized that the proximal end of the stent had partially opened so he advanced a 1.5 non-abbott balloon to fully open the stent then went back in with an nc balloon to fully deploy.There was no adverse patient sequela reported.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned sds and the reported balloon rupture was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints reported from this lot or relabeled lot.The device was visually inspected and prepped prior to use without any damages, leak or ruptures noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.In this case, it is likely that during advancement and/or during stent deployment the balloon became compromised against other devices used or the stent strut resulting in the reported/noted balloon pinhole rupture in the distal balloon shoulder.Additionally, the treatment appears to be related to the operational context of the procedure as a non-abbott device was used to fully open the stent, then fully deployed the stent with an nc balloon.The noted bends on the hypotube and the stretched guide wire exit notch likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 10916340
• Report Number: 2024168-2020-09975
• Device Sequence Number: 16280057
• Product Code: NIQ
• UDI-Device Identifier: 08717648227141
• UDI-Public: 08717648227141
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: 1550250-38
• Device Catalogue Number: 1550250-38
• Device Lot Number: 0063041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/29/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR