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

Model Number	1550400-08
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.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 similar incidents and/or complaints from this lot.The investigation determined the reported difficulties and patient effects appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.(b)(4).
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the proximal right coronary artery.Several attempts were made to advance the xience sierra stent to the lesion, but the stent could not cross a previously implanted stent.During removal, the stent dislodged.Unsuccessful attempts were made to remove the dislodged stent, as it was only able to be moved to the access site in the right radial artery.Contrast was injected, and the dislodged stent was noted to be lodged in a branch between the radial and ulnar arteries, so it was decided to leave it there as it did not limit the flow in the side branch.The final patient outcome was good with no issues.There was no clinically significant delay in the procedure.No additional information was provided.Sus voluntary event report (mw5088723) received reporting: stent came off of the stent catheter delivery system and left in pt's body.The stent was found in the pt's arm in the.Arterial system.Stent was 4.0mm x 08mm.
Additional Manufacturer Narrative
This report is resubmitted to ensure the enclosed attachment can be easily opened by the fda.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: 8937679
• Report Number: 2024168-2019-11226
• Device Sequence Number: 514304
• Product Code: NIQ
• UDI-Device Identifier: 08717648227479
• UDI-Public: 08717648227479
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 07/20/2020

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: 06/05/2020
• Device Model Number: 1550400-08
• Device Catalogue Number: 1550400-08
• Device Lot Number: 9053041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 07/20/2020
• 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
• Patient Age: 85 YR