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

Model Number	1804350-12
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous, 90% stenosed, 12mm lesion in the proximal left anterior descending (plad) artery.A 3.5x12mm xience skypoint drug eluting stent (des) was advanced to the lesion; however, the stent did not fully cover the 12mm lesion, so it was removed.Via angiogram, it was noted that the stent appeared to be not long enough, so a 3.5x15mm xience des was advanced and implanted to cover the lesion and successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The stent will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was returned for analysis.The reported defective device (undersized) was unable to be confirmed; however, it appears that returned product (stent length measurement) is within the product specification for a xience skypoint everolimus eluting coronary stent systems product specification: stent mass & dimensions section.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.As the reported defective device- undersized was unable to be confirmed, the investigation was unable to determine a conclusive cause for the reported defective device (shortened); however, factors that may contribute to defective device (shortened) include, but are not limited to, processing and/or handling in manufacturing, handling during preparation for use, lesion characteristics, procedural technique, product size selection, severe torqueing or kinking of stent (material stress/ fatigue) or interaction with the accessory devices, lesion and/or anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3: device was available for evaluation.
Event or Problem Description
Subsequent to the initial medwatch report, the following information was received: the 3.5x12mm xience skypoint drug eluting stent (des) system was advanced to the lesion, but was noted to be shorter than the lesion, so the complete device, with undeployed stent, was removed from the patient anatomy, without issue.A 3.5x15mm xience des was then advanced and successfully implanted to 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: 16040207
• Report Number: 2024168-2022-13053
• Device Sequence Number: 6218779
• Product Code: NIQ
• UDI-Device Identifier: 08717648233388
• UDI-Public: 08717648233388
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: 02/07/2024
• Device Model Number: 1804350-12
• Device Catalogue Number: 1804350-12
• Device Lot Number: 1020241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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
• Patient Sex: Unknown