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

Model Number	1550300-08
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion with heavy calcification and mild tortuosity in the mid right coronary artery (mrca).During advancement of a 3.0 x 8mm xience sierra stent delivery system (sds), resistance met with the heavy calcification and the stent could not cross the target lesion.Therefore, the sds was removed; however, the stent was not on the balloon.The stent had dislodged in the patient¿s body.A snare was used to retrieve the dislodged stent, and an unspecified sds was used to successfully complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Device 2017 - improper or incorrect procedure or method.Product performance engineering reviewed the incident information; however, 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 difficulties appears to be related to operational circumstances of the procedure.In this case, based on the reported information, during advancement of the stent delivery system (sds) encountered resistance with the heavy calcification and mild tortuosity anatomy causing the failure to advance.Manipulation against resistance during retraction resulted in the reported stent dislodgment.It should be noted that everolimus eluting coronary stent system xience sierra instructions for use states: if unusual resistance is felt before the stent exits the guiding catheter, do not force passage.In this case, the reported violation does not appear to have caused or contributed to the reported complaint.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the devicena.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: excessive force was applied during advancement of the 3.0 x 8mm xience sierra stent delivery system (sds).No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10373810
• Report Number: 2024168-2020-06574
• Device Sequence Number: 2686900
• Product Code: NIQ
• UDI-Device Identifier: 08717648227233
• UDI-Public: 08717648227233
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2021
• Device Model Number: 1550300-08
• Device Catalogue Number: 1550300-08
• Device Lot Number: 806194A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 71