MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1550350-12

Device Problems Unintended System Motion (1430); Patient-Device Incompatibility (2682)

Patient Problem Prolapse (2475)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent remains in the vessel; the customer reported the delivery system was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that during a procedure of the proximal circumflex artery, after pre-dilatation and during stent deployment, the 3.5 x 12 mm xience sierra stent watermelon seeded/moved proximal, partially into the left main (lm) artery, but was implanted in the proximal cx to lm.Plaque shift was noted in the ostial circumflex and the stent was under expanded due to the plaque shift.The ostial cx stent was pinched and the vessel 60 % occluded.Additional dilatation was attempted, but the balloon dilatation catheter could not cross to the stented area.The procedure was terminated with timi3 flow in all vessels.There was no reported adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effect of prolapse is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effect of coronary stenting procedures.A cine was received and reviewed by an abbott vascular clinical specialist which concluded the stent migrated proximally, requiring additional intervention to resolve.It is possible that interaction with the anatomy/plaque as the device was inflated resulted in the reported difficulty to deploy (movement, wall opposition); however, this cannot be confirmed.Additionally, the reported difficulties possibly resulted in the reported patient effects; however, a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7814911
• MDR Text Key: 241263902
• Report Number: 2024168-2018-06590
• Device Sequence Number: 1
• Product Code: NIQ
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Catalogue Number: 1550350-12
• Device Lot Number: 8051842
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 80