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

Model Number	1804225-28
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Codes	Angina (1710); Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mid left anterior descending artery(lad) with moderate tortuosity and heavy calcification a 2.0 x 8mm non-abbott stent was placed in the distal lad.Then a 2.25 x 28mm xience skypoint stent delivery system (sds) was attempted to be advanced to the mid lad, but the stent failed to cross the target lesion due to the anatomy.The sds was removed from the patient.Additional dilatation was performed with a 2.25 and 2.5 mm unspecified balloons.When the 2.5 unspecified balloon was removed, an unspecified wire that was previously placed in the lad and diagonal artery came out.Then thrombosis was observed in the circumflex artery.The patient developed chest pain and an intra-aortic balloon pump (iabp) was placed.It is unknown at this time if the sds contributed to the thrombosis.The circumflex artery was treated with an unspecified stent, but the lad was unable to be revascularized.There was no clinically significant delay in the procedure.No additional information was provided.
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
Subsequent to the initially filed report, the following information was received: it was reported that the physician stated that the thrombosis was due to hypercoagulable from covid, and the 2.25 x 28mm xience skypoint stent delivery system (sds) that failed to cross due to anatomical challenges did not cause or contribute to the thrombosis.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 did not indicate a lot specific quality issue.A conclusive cause for the reported failure to advance could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: health codes 1710, 4440, and 4641 were removed.

• 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: 13293785
• Report Number: 2024168-2022-00654
• Device Sequence Number: 17279908
• Product Code: NIQ
• UDI-Device Identifier: 08717648233029
• UDI-Public: 08717648233029
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 06/22/2023
• Device Model Number: 1804225-28
• Device Catalogue Number: 1804225-28
• Device Lot Number: 1061041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/01/2022
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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