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

Model Number	1804300-08
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and not returned.The lot history record (lhr) for this product could not be reviewed and a similar complaint query of the complaint handling system could not be performed because the product was not returned for evaluation and the lot number was not reported.The investigation determined the reported dislodged stent and subsequent treatment appear to be related to the operational context of the procedure.Additionally, the reported removal of foreign body was due to a dislodged stent within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified lesion in the proximal left anterior descending (plad) artery.A 3x8mm xience skypoint drug eluting stent (des) was advanced through a xience stent that was implanted 2 days earlier.When pulling back to position the stent at the target lesion, the 3x8mm xience skypoint stent interacted with the previously implanted stent and dislodged from the balloon, distal to the implanted stent.A snare was used, and the dislodged stent was successfully removed.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.The lesion was ballooned with an unspecified balloon to successfully complete the procedure.No additional information was provided.

• 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: 15136368
• Report Number: 2024168-2022-08382
• Device Sequence Number: 5120038
• Product Code: NIQ
• UDI-Device Identifier: 08717648233210
• UDI-Public: 08717648233210
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/29/2022

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 Model Number: 1804300-08
• Device Catalogue Number: 1804300-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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