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

Catalog Number 1500300-15

Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device will not be returning.The 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 a lesion in the left anterior descending coronary artery.A 3x15mm xience sierra stent was implanted without difficulty.An unspecified guide wire was advanced but failed to cross the xience sierra stent, so a non-abbott guide wire was advanced which interacted with the previous guide wire.The stent then became caught in the guide wires and was explanted when the guide wires were retrieved using a lasso through an unspecified introducer sheath.An unspecified stent was then used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The product was not returned to abbott vascular 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 other similar incidents and/or complaints reported from this lot.The investigation determined the reported difficulty to advance and device damaged by another device appears to be related to operational circumstances of the procedure.Based on the reported information, during attempt to advance an unspecified guide wire through the previously implanted xience sierra stent, the guide wire had difficulty advancing.A second non-abbott guide wire was also advanced and likely tangled with the first guide wire and stent.Manipulation of the guide wires inadvertently explanted the stent for the implanted location.Additionally, treatment appears to be related to circumstances of the procedure as a lasso was advanced and successfully removed the guide wires and stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Correction to case details: it was reported that the procedure was performed to treat a lesion in the left anterior descending coronary artery.A 3x15mm xience sierra stent was implanted without difficulty.An unspecified guide wire was advanced but failed to cross the xience sierra stent, so a non-abbott guide wire was advanced which interacted with the previous guide wire.The stent then became caught in the guide wires and was inadvertently explanted.A lasso was advanced and successfully removed the guide wires and stent.An unspecified stent was then used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.B1/b2: adverse event/required intervention added b5: case details corrected.H1: type of reportable event changed from malfunction to serious injury.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10518337
• MDR Text Key: 217674991
• Report Number: 2024168-2020-07587
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2023
• Device Catalogue Number: 1500300-15
• Device Lot Number: 0030441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7F INTRODUCER SHEATH; RUNTHROUGH GUIDE WIRE
• Patient Outcome(s): Required Intervention