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

Model Number	1550300-23
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for evaluation.It has not yet been received.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 an unspecified artery.During removal of the protective sheath from a 3.0x23 mm xience sierra stent delivery system (sds), it was noted that the stent implant appeared to be wavy.Despite this, the sds was advanced and balloon inflation was performed to deploy the stent.The sds was removed with resistance at the y-connector.Post-dilatation was then performed with a 3.5x12 mm non-abbott balloon dilatation catheter (bdc); however, on removal of the bdc, resistance was also felt with the y-connector and it was noted that the xience sierra stent had come out of the anatomy with the bdc.On re-checking the cine images, it was observed that the stent was not mounted on the balloon of the sds when it reached the target lesion and the balloon was inflated without the stent.The physician thought that the stent dislodged in the guiding catheter during the delivery after passing through the y-connector.Another same size unspecified stent was 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.
Event or Problem Description
Subsequent to the initial report, additional reported information indicates that the physician recognized the stent had dislodged before the sds reached the target lesion.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement and material deformation was confirmed.The reported difficult to remove could not be tested due to the condition of the returned device.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure, as it is likely that inadvertent mishandling during protective sheath/stylet removal resulted in the noted smashed middle portion of the stent implant.Interaction with the guide catheter and y-connector during advancement likely contributed to the reported stent dislodgement.Further interaction with the guide catheter / y-connector during retraction of the device, as resistance was reported, likely contributed to the reported material deformation (bent and stretched struts at the proximal end of the stent implant) in addition to the noted bent support skive/wire/bayonet, causing the reported difficult to remove.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) states to carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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: 10659368
• Report Number: 2024168-2020-08459
• Device Sequence Number: 3529307
• Product Code: NIQ
• UDI-Device Identifier: 08717648227271
• UDI-Public: 08717648227271
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2023
• Device Model Number: 1550300-23
• Device Catalogue Number: 1550300-23
• Device Lot Number: 0050341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1