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

Catalog Number	1804225-12
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, heavily tortuous, 90% stenosed, de novo lesion in the mid-left circumflex (mlcx) artery.After pre-dilatation, the 2.25x12mm xience skypoint drug eluting stent (des) was advanced to the lesion with resistance from the anatomy.As the des was being inflated, it was noted that the stent had dislodged in the proximal left circumflex.The des was unable to be retrieved so it was crushed, with a non-abbott balloon, to the vessel wall.A 3.5x15 xience skypoint des was then deployed over the crushed stent.Kissing balloon technique (kbt) was performed and a non-abbott device was used to successfully complete the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported dislodgement was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment as it was 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 similar incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the mildly calcified, heavily tortuous and 90% stenosed anatomy resulting in the reported difficult to advance.Manipulation and/or interaction with the mildly calcified, heavily tortuous and 90% stenosed anatomy and/or other devices resulted in the reported stent dislodgement.The treatments appear to be related to the operational context of the procedure as reportedly the stent was unable to be retrieved so it was crushed, with a non-abbott balloon, to the vessel wall.A 3.5x15 xience skypoint stent was then deployed over the crushed stent.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
• MDR Report Key: 11369508
• Report Number: 2024168-2021-01409
• Device Sequence Number: 3781949
• Product Code: NIQ
• UDI-Device Identifier: 08717648232985
• UDI-Public: 08717648232985
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2023
• Device Catalogue Number: 1804225-12
• Device Lot Number: 0090341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention