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

Model Number 1550225-15

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that would have contributed to this event.Based on review of the similar incidents, there is no indication of a lot specific issue.The investigation determined the reported failure to advance, difficulty to remove and stent dislodgement appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the anatomical condition caused resistance during advancement which then caused the stent delivery system to become caught in the previously implanted stent.Manipulation against resistance likely resulted in the reported stent dislodgment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a concentric, heavily calcified, heavily tortuous, 90% stenosed, de novo proximal left circumflex (plcx).After lesion pre-dilatation, a 2.25x15mm xience sierra drug eluting stent (des) was advanced but due to the anatomy, became stuck with a the previously implanted stent in the circumflex and dislodged.A snare was attempted to grab it and pull it out but failed.A non-abbott device was used to push the dislodged sierra stent against the previously implanted stent and another sierra stent was advanced and implanted to embed the dislodged stent into the previously implanted stent.Post- dilatation was performed.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.The lesion was again pre-dilated and a non-abbott stent was implanted to complete the procedure.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10550402
• MDR Text Key: 207492108
• Report Number: 2024168-2020-07820
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227011
• UDI-Public: 08717648227011
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2021
• Device Model Number: 1550225-15
• Device Catalogue Number: 1550225-15
• Device Lot Number: 811284A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 88