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

Model Number	1550350-08
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that during device preparation of the xience sierra stent system, there was an unusual feeling when removing the protective sheath and stylet; however, the device was used in the anatomy to treat a lesion located in the mildly calcified and 90% stenosed right coronary artery.When delivered to the lesion, it was noted that a stent was not on the balloon and was later found stuck on the protective sheath.There was no adverse patient effect or clinically significant delay.A same size non-abbott stent was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned stent delivery system.The reported difficulty to remove the protective sheath and stent dislodgment were unable to be confirmed as the protective sheath was not returned and the stent implant was returned tightly crimped and stationary on the balloon between the markers as intended without any damage noted.A review of the lot history record identified no manufacturing non-conformities 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.Factors that may contribute to difficulty removing the protective sheath may include, but not limited to, normal variation within the manufacturing process, protective sheath removal technique, damage during manufacturing, damage to the protective sheath, an undersized sheath and/or an oversized balloon profile and stent, mishandling or positive pressure applied during preparation.To ensure this type of issue is not the result of a manufacturing quality issue, all products are 100% visually inspected for damage.The investigation was unable to determine a conclusive cause for the reported difficulty to remove the protective sheath and stent dislodgement.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 10340895
• Report Number: 2024168-2020-06298
• Device Sequence Number: 2979158
• Product Code: NIQ
• UDI-Device Identifier: 08717648227394
• UDI-Public: 08717648227394
• 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): 08/24/2020

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: 05/09/2021
• Device Model Number: 1550350-08
• Device Catalogue Number: 1550350-08
• Device Lot Number: 804264A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR