MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1550350-18
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Damaged by Another Device (2915); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device is retained by the hospital.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery via right radial access.The 3.5x18 mm xience sierra stent was first implanted in the proximal lad (plad) and was possibly under expanded.Next, the physician went through the stent in the plad to place a 3.0x18 mm xience sierra stent in the mlad with no issues reported.Next, the circumflex (cx) coronary artery was wired through a strut of the 3.5x18 xience sierra stent and it was attempted to place a 3.5x12mm xience sierra stent in the cx but the stent would not cross the previously implanted stent.The stent was removed without issue and there were no other issues noted.The physician removed both guide wires and the guide catheter and when they were removed, the 3.5x18 mm xience sierra stent was found on the end of the guide catheter unraveled.The procedure was completed.The patient is stable and being discharged and plans to return in 1 week to have another angiography performed.No additional information was provided.
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.The investigation determined that the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT 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: 10179695
• Report Number: 2024168-2020-05207
• Device Sequence Number: 2850362
• Product Code: NIQ
• UDI-Device Identifier: 08717648227424
• UDI-Public: 08717648227424
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 03/30/2021
• Device Model Number: 1550350-18
• Device Catalogue Number: 1550350-18
• Device Lot Number: 0032043
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 08/06/2020
• 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: 3.5X12 MM, 3.0X18 MM XIENCE SIERRA; 3.5X12 MM, 3.0X18 MM XIENCE SIERRA
• Patient Age: 61 YR
• Patient Weight: 96