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

Model Number	1804225-15
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the heavily calcified, heavily tortuous right coronary artery (rca) with advanced disease.The xience skypoint stent delivery system (sds) was advanced with slight resistance noted but it was noted that the stent was not seen on the delivery system and the stent was seen floating in the obtuse marginal artery.A mini trek balloon dilatation catheter (bdc) was advanced and inflated slightly in order to move the stent to the indented location and the stent was deployed with additional dilatations.A dissection was noted distally and 10 xience stents were layered to treat the dissection.Ten xience stents were required due to advanced disease state in the rca, including numerous ruptured plaques and stenosed areas combined with difficult, calcified, tortuous anatomy required shorter stents to deliver for treatment.No additional information was provided.
Additional Manufacturer Narrative
The device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The udi is unknown due to the part/lot number were not provided.
Event or Problem Description
It was reported that the procedure was to treat the heavily calcified, heavily tortuous right coronary artery (rca) with advanced disease.The xience skypoint stent delivery system (sds) was advanced with slight resistance noted but it was noted that the stent was not seen on the delivery system and the stent was seen floating in the obtuse marginal artery.A mini trek balloon dilatation catheter (bdc) was advanced and inflated slightly in order to move the stent to the intended location and the stent was deployed with additional dilatations.A dissection was noted distally and 10 xience stents were layered to treat the dissection.Ten xience stents were required due to advanced disease state in the rca, including numerous ruptured plaques and stenosed areas combined with difficult, calcified, tortuous anatomy required shorter stents to deliver for treatment.Subsequent to the initially filed report the following information was provided: the device was a 2.5x15 mm xience skypoint sds.No additional information was provided.
Additional Manufacturer Narrative
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 identified no similar incidents from this lot.The reported patient effect of dissection is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the difficult anatomy causing the reported failure to advance and subsequent stent dislodgement.A balloon catheter was used to place the stent in the intended location successfully.A dissection was noted after the stent was placed and treated with additional xience stents.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 13524693
• Report Number: 2024168-2022-01499
• Device Sequence Number: 14764404
• Product Code: NIQ
• UDI-Device Identifier: 08717648232992
• UDI-Public: 08717648232992
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2022

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: 04/06/2023
• Device Model Number: 1804225-15
• Device Catalogue Number: 1804225-15
• Device Lot Number: 1040141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown