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

Model Number	1804325-38
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) states: if unusual resistance is felt before the stent exits the guiding catheter, do not force passage.Resistance may indicate a problem and the use of excessive force may result in stent damage or dislodgement.Maintain guide wire placement across the lesion and remove the delivery system and guiding catheter as a single unit.It is unknown if the ifu deviation contributed to the reported event.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties and subsequent treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no product-related corrective action will be implemented in this case.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified vessel in the left circumflex (lcx) artery.The 3.25x38mm xience skypoint stent delivery system (sds) was advanced and jammed [advanced against resistance] several times against the heavy calcification, causing the stent to dislodge.The stent was hanging in the sheath; the stent [sds] was manipulated and the stent came off the sheath and into the femoral artery.The stent was retrieved by a snare device into the guiding catheter and the stent and guiding catheter were removed together.The lesion was pre-dilatated with a 3.0x25 nc trek and another same size xience skypoint completed the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.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: 12515695
• Report Number: 2024168-2021-08459
• Device Sequence Number: 5121956
• Product Code: NIQ
• UDI-Device Identifier: 08717648233364
• UDI-Public: 08717648233364
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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: 03/18/2023
• Device Model Number: 1804325-38
• Device Catalogue Number: 1804325-38
• Device Lot Number: 1031241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/22/2021
• 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
• Patient Age: 75 YR