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

Model Number	1804250-08
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the mildly calcified, 90% stenosed right posterior descending coronary artery.A non-abbott stent was first placed in the proximal portion of the artery but stenosis was seen distally so the 2.5x8 mm xience skypoint stent delivery system (sds) was attempted to be advanced.The sds could not cross the lesion and when pulling back it felt like there was resistance with the non-abbott stent and when pulling into the guide catheter.When removed from the body it was found that the stent was flared.Another same size xience skypoint was used to complete the procedure.There were no adverse patient effects and there was 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.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material deformation was confirmed.The reported failure to advance and difficulty to remove (stent) could not be replicated in a testing environment as they were related to operational context of the procedure.The reported difficulty to remove (guide catheter) could not be confirmed due to the condition the device was received for evaluation.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 determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the difficult anatomy causing the reported failure to advance.During removal the device likely interacted with the previously implanted stent and guiding catheter causing the reported difficulty to remove and subsequent material deformation.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: 12953674
• Report Number: 2024168-2021-11189
• Device Sequence Number: 4217241
• Product Code: NIQ
• UDI-Device Identifier: 08717648233050
• UDI-Public: 08717648233050
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: 12/07/2023
• Device Model Number: 1804250-08
• Device Catalogue Number: 1804250-08
• Device Lot Number: 0120241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 01/08/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2020
• 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: MACHI 1 GUIDE CATHETER; ORSIRO STENT
• Patient Sex: Unknown