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

Catalog Number	1550225-12
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.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.H3 other text : the customer reported the device was discarded.
Event or Problem Description
It was reported that the procedure was to treat the circumflex artery.The patient was exposed to 26 gy (gray) of radiation.A 2.25 x 12 mm xience sierra stent delivery system was used and a stent dislodgement was reported.No additional information was provided.
Additional Manufacturer Narrative
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 similar incidents from this lot.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8888172
• Report Number: 2024168-2019-10798
• Device Sequence Number: 16201544
• Product Code: NIQ
• UDI-Device Identifier: 08717648227004
• UDI-Public: 08717648227004
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/17/2019

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: 01/01/2020
• Device Catalogue Number: 1550225-12
• Device Lot Number: 8121841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/17/2019
• 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: Other; Disability