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

Model Number 1550400-15

Device Problems Malposition of Device (2616); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2020

Event Type  Injury  

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 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.

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
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9800185
• MDR Text Key: 182600870
• Report Number: 2024168-2020-02075
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227493
• UDI-Public: 08717648227493
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention