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	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.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 to treat a heavily calcified, mildly tortuous, mid-right coronary artery (mrca).Pre-dilation was successfully performed and a 3x23mm xience sierra drug eluting stent (des) delivery system was advanced; however, the stent was unable to cross the lesion.The des was removed, and additional pre-dilation was performed a second time with a different size catheter.The stent was advanced a second time but did not cross the lesion once again.The stent was removed and a third, different sized catheter was attempted but the des was still unable to cross the lesion and was withdrawn from the anatomy.After removing the device on the third attempt, it was observed that the stent was no longer on the balloon.Imaging showed that the stent was still crimped and was stuck in the proximal rca.The procedure was discontinued, and the patient was immediately transferred to a nearby hospital for additional intervention.There was no adverse patient sequela reported in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties and subsequent treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture 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: 10781903
• Report Number: 2024168-2020-09204
• Device Sequence Number: 3318301
• Product Code: NIQ
• UDI-Device Identifier: 08717648227271
• UDI-Public: 08717648227271
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 01/12/2021

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: 12/08/2021
• Device Model Number: 1550300-23
• Device Catalogue Number: 1550300-23
• Device Lot Number: 0060241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 87