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

Catalog Number	1804275-18
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the 1st diagonal in the left anterior descending (lad) coronary artery that was heavily calcified.Reportedly, the nc trek neo rx 3.00 x 12mm was advanced first in the distal lad.Then, the xience skypoint des 2.75 x 18 rx us stent delivery system was unable to advance out of the guide catheter.The physician lost guide engagement and wire position, and pulled both devices into the guide catheter.Once the guide catheter was re-engaged, and the physician had wire placement, the nc trek neo was re-advanced into the distal lad (but not inflated).The sds was unable to advance, with resistance.Then the sds was removed and noticed that the stent had separated from the shaft outside the patient.The nc trek neo appeared to be kinked on the shaft.Both devices were not able to be used and set aside.A new stent and balloon of the same size were opened and successfully used.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment due to the condition of the returned device.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other similar incidents from this lot.As there was no damage noted to the device during the inspection prior to use.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the guiding catheter and/or other devices resulted in the reported difficult to advance.Manipulation of the device resulted in the noted device damages (torn guide wire exit notch, multiple hypotube bends/kinks) further contributing to the reported difficult to advance and ultimately resulted in the reported/noted material separation.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the initial report being filed, the reported details were reviewed and it was been noted that the separation was reported to be at the shaft/hypotube.There was no stent separation.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: 18899111
• Report Number: 2024168-2024-03291
• Device Sequence Number: 18062847
• Product Code: NIQ
• UDI-Device Identifier: 08717648233166
• UDI-Public: (01)08717648233166(17)260620(10)3062841
• 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,Followup
• Report Date (Section B): 06/06/2024

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: 06/20/2026
• Device Catalogue Number: 1804275-18
• Device Lot Number: 3062841
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NC TREK NEO 3.0X12MM.
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 95 KG