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

Catalog Number 1500300-18

Device Problem Difficult to Advance (2920)

Patient Problems Occlusion (1984); Pain (1994)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on dec 21, 2018, a 3.0x18mm xience sierra stent was implanted in the left anterior descending artery (lad).Patient followed 6 months of plavix and aspirin after procedure.On (b)(6) 2020, the patient showed symptoms relating to discomfort and distress.On (b)(6) 2020, the patient was re-hospitalized as angiographic images were reviewed noting that the lad lesion was blocked.It could not be determined if it was thrombosis or restenosis.A balance middle weight guide wire was unable to cross the previously implanted xience sierra so a non-abbott guide wire was used successfully to cross.A 2.5x15mm trek balloon was then inflated twice.Five 3.0x23mm xience sierra stents were placed proximal and inside to the previously implanted 3.0x18mm xience sierra stent, as treatment.The patient was deemed fine.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 reported patient effect of occlusion and pain are listed in electronic instructions for use everolimus eluting coronary stent systems, xience sierra, ce as known patient effects of coronary stenting procedures.A cine was received and reviewed by an abbott vascular clinical specialist.The cine review concluded that the still images, the initial pictures suggest the occlusion may be proximal to the stent, which does suggest an edge effect or possibly geographical miss ¿ although thrombus can extend proximally from within the stent.Two of the still images hint at underexpansion in the stented segment, but this is impossible to be sure of without moving images and a high-res monitor.The investigation was unable to determine a conclusive cause for the reported difficulty to advance, the reported patient effects and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 10206327
• MDR Text Key: 197123344
• Report Number: 2024168-2020-05395
• 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
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2021
• Device Catalogue Number: 1500300-18
• Device Lot Number: 8082741
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCE MIDDLEWEIGHT GUIDE WIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 76