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

Model Number	1550300-18
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
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 device has been 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 during a left anterior descending coronary artery intervention, the xience sierra stent was advanced to the lesion without issue; however, during deployment, the balloon would not inflate past 12 atmospheres and a shaft leak was suspected.The stent was implanted, requiring balloon dilatation to fully expand the stent and treat the lesion.There was no adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported leak and inflation issues were confirmed.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 other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported leak; however, factors that may contribute to leaks include, but are not limited to, material damage, interactions with other devices or interaction with lesion calcification and tortuosity.The reported inflation issues appear to be related to operational context of the procedure as it is like the outer member leak caused the reported inflation issues and subsequent additional therapy/non-surgical procedure.There was no damage or leak noted to the stent delivery system (sds) during manufacturing which requires all devices to be pressurized twice to 210 pounds per square inch (psi) for pressure integrity prior to release for use and there were no other incidents with this type of damage reported for this finished good lot.Additionally, there was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: RX 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: 9597387
• Report Number: 2024168-2020-00741
• Device Sequence Number: 14084781
• Product Code: NIQ
• UDI-Device Identifier: 08717648227264
• UDI-Public: 08717648227264
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 02/04/2022
• Device Model Number: 1550300-18
• Device Catalogue Number: 1550300-18
• Device Lot Number: 9012941
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/01/2020
• 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