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); Failure to Advance (2524); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.User facility medwatch report: mw5111021.
Event or Problem Description
User facility medwatch report (mw5111021) received stating: "stent used during coronary ptca was unable to be advanced, so it was removed.There was difficulty removing it through the guard catheter.Everything was pulled out, catheter, guidewire and stent.Upon observation, the stent had become torn or damaged at the base.Abbott xience skypoint 2.75 mm x18 mm, ref 1804275-18, lot 1120641.Fda safety report id # (b)(4).Additional information received: after lesion preparation, the 2.75x18mm xience skypoint stent delivery system (sds) failed to advance due to heavy calcium and moderate tortuosity 90+% stenosed lesion in the mid right coronary artery (mrca).After removal of the sds, the distal end of the stent had a noted deformity due to the dottering technique on the calcium.Another 2.75mm x 18 mm xience skypoint stent was deployed.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported material split, cut or torn could not be confirmed.The first three rings at the proximal end of the stent implant were mangle.The stent implant was not torn as reported.The reported failure to advance could not be tested as it was based on operational context.The reported difficult to remove could not be tested due to the device condition.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported failure to advance and difficult to remove appear to be related to the operational context of the procedure; however, the investigation was unable to determine a conclusive cause for the reported material split/torn/cut.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: 15280205
• Report Number: 2024168-2022-09081
• Device Sequence Number: 11361093
• Product Code: NIQ
• UDI-Device Identifier: 08717648233166
• UDI-Public: 08717648233166
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 12/12/2023
• Device Model Number: 1804275-18
• Device Catalogue Number: 1804275-18
• Device Lot Number: 1120641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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 Age: 70 YR
• Patient Sex: Male