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

Model Number	1804450-28
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right coronary artery (rca), with none calcification and none tortuosity.The balloon of the 4.50x28 mm xience skypoint stent delivery system (sds) was inflated once at 18 atmospheres for 40 seconds.Negative pressure was held for the entire removal.The balloon met resistance during removal and was removed partially deflated with the non-abbott guide catheter extension.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Device code 2017 clarifier- above rbpna.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficulties deflating the balloon was unable to be confirmed.The reported difficulty removing the device from the anatomy could not be replicated in a testing environment as they are based on operational circumstances.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 other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported deflation problem as no issue was identified during return device analysis.The reported difficulty to remove the device appears to be related to operational context of the procedure as it is likely the partially inflated balloon interacted with the guiding catheter.It was reported that the balloon of the 4.50x28 mm xience skypoint stent delivery system (sds) was inflated once at 18 atmospheres for 40 seconds.Negative pressure was held for the entire removal.The balloon met resistance during removal and was removed partially deflated with the non-abbott guide catheter extension.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use (ifu), 1.0 device description the rated burst pressure (rbp) should be 16 atmospheres, section 10.0 precautions it states, ¿do not exceed the rated burst pressure (brp) as indicated in the product label.¿ additionally, per ifu section 10.4 stent /system removal: if during withdrawal of the catheter from the deployed stent, resistance is met steps need to be taken to improve balloon rewrap.The balloon needs to be re-inflated to nominal pressure, deflate and change the pressure to neutral.Per the account the balloon was inflated only once.In this case, it is unknown if the reported ifu violations caused or contributed to the reported complaint.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: 16293370
• Report Number: 2024168-2023-01123
• Device Sequence Number: 6408673
• Product Code: NIQ
• UDI-Device Identifier: 08717648233586
• UDI-Public: 08717648233586
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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): 03/31/2023

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: 03/15/2024
• Device Model Number: 1804450-28
• Device Catalogue Number: 1804450-28
• Device Lot Number: 2030341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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: NON-ABBOTT GUIDELINER
• Patient Sex: Unknown