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

Model Number	1550350-28
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Embolism (1829); Foreign Body In Patient (2687)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.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 reported patient effect of embolism is listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in an unspecified vessel.Atherectomy was performed using a non-abbott device.The 3.5 x 28 mm xience sierra stent delivery system was then advanced.Resistance was noted at the target site and force was applied.The xience sierra stent dislodged and embolized to the left iliac artery.A balloon dilatation catheter was advanced to the dislodged stent, and inflated, crushing the stent to the vessel wall.Angiography noted that the stent appeared to be well crushed to the vessel wall.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: 10582893
• Report Number: 2024168-2020-07990
• Device Sequence Number: 1167853
• Product Code: NIQ
• UDI-Device Identifier: 08717648227448
• UDI-Public: 08717648227448
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 09/24/2020

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: 12/15/2021
• Device Model Number: 1550350-28
• Device Catalogue Number: 1550350-28
• Device Lot Number: 0060242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/24/2020
• 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