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

Model Number	1804300-38
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 identified no other incidents.In this case, it is likely the device interacted with the mildly calcified, moderately tortuous lesion during advancement, as resistance was noted, resulting in the reported failure to advance.Further interaction with the challenging anatomy during retraction of the device, as resistance was again noted, likely kinked the shaft, causing the reported deformation due to compressive stress, resulting in the reported difficult to remove.The investigation determined the reported difficulties 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.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, moderately tortuous lesion in the right coronary artery (rca).A non-abbott guide wire (gw) was advanced to the lesion and plain old balloon angioplasty (poba) was completed with an unspecified 2.5mm balloon.A 3x38mm xience skypoint drug eluting stent (des) was then advanced with resistance from the anatomy and could not reach the target lesion.Upon removal of the des, resistance was noted with the anatomy and a kink in the shaft was observed.The procedure was completed, as is.There was no adverse patient effect 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: 12721314
• Report Number: 2024168-2021-09733
• Device Sequence Number: 1364024
• Product Code: NIQ
• UDI-Device Identifier: 08717648233289
• UDI-Public: 08717648233289
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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 Expiration Date: 03/04/2024
• Device Model Number: 1804300-38
• Device Catalogue Number: 1804300-38
• Device Lot Number: 1030241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/29/2021
• 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: JR4.0