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

Model Number	1804275-18
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.In this case, it is likely that the device interacted with another skypoint stent delivery systems (sds) inside the unspecified 6fr guide catheter during advancement, as resistance was reported, resulting in the reported difficult to advance/position and difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other xience skypoint referenced is filed under a separate medwatch report.The other xience skypoint referenced is filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified lesion in the mildly tortuous proximal left circumflex artery (plcx).Two xience skypoint stent delivery systems were advanced at the same time inside the guiding catheter (gc); however, the devices became stuck during advancement and were difficult to remove from the gc.There were no adverse patient effects and no clinically significant delay in the procedure.The procedure was completed using a non-abbott device.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
• MDR Report Key: 12289444
• Report Number: 2024168-2021-06911
• Device Sequence Number: 3130531
• Product Code: NIQ
• UDI-Device Identifier: 08717648233166
• UDI-Public: 08717648233166
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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: 1804275-18
• Device Catalogue Number: 1804275-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XIENCE SKYPOINT DES 2.25 X 12