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

Model Number	1804300-38
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the electronic lot history record (elhr) and similar incident review for this product was not performed because the lot number was not reported and the product was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported deflation problem; however, it appears that the reported difficult to remove was due to operational context.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Event date: estimated date.
Event or Problem Description
It was reported that the 3.0x38mm xience skypoint stent delivery system (sds) was deployed; however, the balloon only partially deflated.During removal resistance was met with the unspecified guiding catheter.No other device was needed to complete the procedure.There was no adverse patient effects reported and no clinically significant delay reported.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: 16293811
• Report Number: 2024168-2023-01128
• Device Sequence Number: 12375404
• Product Code: NIQ
• UDI-Device Identifier: 08717648233289
• UDI-Public: 08717648233289
• 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
• Report Date (Section B): 02/03/2023

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 Model Number: 1804300-38
• Device Catalogue Number: 1804300-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/03/2023
• 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
• Patient Sex: Unknown