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

Model Number 1550250-12

Device Problem Device Damaged by Another Device (2915)

Patient Problem Occlusion (1984)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the 2.5x12 mm xience sierra stent was implanted in the left circumflex (lcx) coronary artery, but it jailed the obtuse marginal (om) side branch.The doctor intended to advance a guidewire through the already deployed stent strut in order to deploy another stent through the sierra for the om.The guidewire was advanced through the stent strut, but on fluoro, the guidewire had prolapsed.The guidewire was retracted when it was noted that the stent was no longer in the lcx.It was suspected that the guidewire had prolapsed around the stent, such that, when the guidewire was pulled back, the stent came with it.The stent was retracted into the guide catheter and was removed together as a unit with the guidewire and guide catheter.The procedure continued with a new guidewire to the om.A xience sierra stent was implanted in the om followed by another sierra in the lcx.There were no adverse patient effects and no clinically significant delay in the procedure.The patient was fine and was discharged home.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported device damaged by another (explanted) was confirmed through observation.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 reported patient effect of occlusion is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

N/a.

• 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: 9593263
• MDR Text Key: 178336158
• Report Number: 2024168-2020-00709
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227080
• UDI-Public: 08717648227080
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2020
• Device Model Number: 1550250-12
• Device Catalogue Number: 1550250-12
• Device Lot Number: 9060441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR