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

Model Number	1550400-15
Medical Device Problem Codes	Malposition of Device (2616); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in the patient.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 performed to treat heavy tortuous, heavy calcified and 90% stenosis lesion in the mid right coronary artery.It was noted that pre-dilatation was not performed.A xience sierra 4.00x15 rx was advanced, but resistance was noted.The stent was continued to be advanced; however, the stent then dislodged.The physician stated the dislodged stent was due to not performing pre-dilatation.A small diameter balloon was then inserted and shifted the stent to the proximal lesion.The balloon dilated the stent, but it was noted that the stent was implanted at a more proximal position then planned; therefore, an additional stent was implanted.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 similar incidents from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the stent interacted with the heavily tortuous, heavily calcified and stenosed lesion causing the reported difficulty to advance and subsequent stent dislodgement with additional therapy/non-surgical treatment.The device was then deployed with a post balloon proximal to the intended location resulting in the malposition of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 2616 added.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9800185
• Report Number: 2024168-2020-02075
• Device Sequence Number: 14145898
• Product Code: NIQ
• UDI-Device Identifier: 08717648227493
• UDI-Public: 08717648227493
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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: 03/13/2021
• Device Model Number: 1550400-15
• Device Catalogue Number: 1550400-15
• Device Lot Number: 8030541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 03/27/2020
• 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