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

Model Number	1804225-12
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
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 to treat the first obtuse marginal artery.An unspecified guide wire crossed and a 2.25x12mm xience skypoint stent delivery system (sds) was advanced; however, failed to inflate.Once removed the sds was flushed with saline and a leak was noted around the proximal stent edge.Another 2.25x12mm xience skypoint was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat the first obtuse marginal artery.An unspecified guide wire crossed and a 2.25x12mm xience skypoint stent delivery system (sds) was advanced; however, failed to inflate.Once removed the sds was flushed with saline and a leak was noted around the proximal stent edge.Another 2.25x12mm xience skypoint was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.Subsequently, after the initial report was filed it was noted prior to use the stent delivery system was not air aspirated outside the anatomy.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 2017 incorrect prep.A visual and functional inspection were performed on the returned device.The reported leak and expansion failure 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 similar incidents from this lot.It was reported that the device was prepared (air aspiration) inside the anatomy.It should be noted that the xience skypoint instructions for use (ifu) states: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach it to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.It is unknown if the ifu deviation directly caused or contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported difficulties; however, factors that could contribute to a leak include, but are not limited to, inflation above rated burst pressure, interaction with accessory devices, and/or patient¿s disease state.Factors that could contribute to an expansion failure include, but are not limited to, inflation technique, loose connection with the indeflator, contamination in the inflation lumen, and/or damage to the inflation lumen.There was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is possible that interaction between the sds and an accessory device during advancement/deployment may have resulted in the noted pinholes on the balloon and ultimately contributed to the reported leak and subsequent expansion failure; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: medical device problem code 2017 - incorrect prep was added.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13760530
• Report Number: 2024168-2022-02627
• Device Sequence Number: 2481270
• Product Code: NIQ
• UDI-Device Identifier: 08717648232985
• UDI-Public: 08717648232985
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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: 11/03/2023
• Device Model Number: 1804225-12
• Device Catalogue Number: 1804225-12
• Device Lot Number: 0102341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown