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

Model Number	1550350-23
Medical Device Problem Codes	Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Activation Failure (3270); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned 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 incidents from this lot.It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use (ifu) lists stent preparation to be performed prior to delivery procedure.In this case, it is unknown if the ifu deviation related to incorrect stent preparation may have contributed to the reported event.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the anatomy causing the reported difficulty to advance.Handling and/or manipulation of the device in combination with interaction with the guide wire during difficult advancement likely caused the reported tear at the guide wire exit notch.It is likely the reported shaft tear caused the reported inflation issue and activation failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience sierra device is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that a 3.5x23mm xience sierra stent delivery system (sds) was not prepped (air aspirated) prior to use.The sds was advanced; however, resistance with the anatomy was felt.Once at the target lesion, an attempt to inflate the sds was made but it was noted that the shaft near the guide wire port was torn.No leak was noted; however, this resulted in the inability to inflate the sds and deploy the stent.The sds with stent were removed.An attempt to advance a 2.5x12mm xience sierra sds was made; however, the sds could not cross due to resistance with the anatomy.The sds was removed and it was noted that the stent had dislodged and was missing.The stent was found outside the body on the gauze used to wipe down the wire after the sds was removed.The procedure was successfully completed with other unspecified stents.There were no adverse patient effects and no clinically significant delay in the procedure.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: 10186611
• Report Number: 2024168-2020-05278
• Device Sequence Number: 19041479
• Product Code: NIQ
• UDI-Device Identifier: 08717648227431
• UDI-Public: 08717648227431
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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: 12/12/2020
• Device Model Number: 1550350-23
• Device Catalogue Number: 1550350-23
• Device Lot Number: 9120941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1