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

Catalog Number	1074400-23
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2018
Type of Reportable Event	Malfunction
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.Na h3 other text : the customer reported the device was discarded.
Event or Problem Description
It was reported that the procedure was to treat an unspecified coronary artery.A 4.0 x 23 mm xience xpedition stent delivery system was used; however, it was noted that the stent was missing when there was an attempt to deploy it.Therefore, the sds was replaced with another unspecified device to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported failure to deploy.There is no indication of a product quality issue with respect to manufacture, design or labeling.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.
Event or Problem Description
It was reported that the procedure was to treat an unspecified coronary artery.A 4.0 x 23 mm xience xpedition stent delivery system was used; however, the stent failed to deploy.Therefore, the sds was replaced with another unspecified device to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE XPEDITION
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8827961
• Report Number: 2024168-2019-10373
• Device Sequence Number: 19586106
• Product Code: NIQ
• UDI-Device Identifier: 08717648162657
• UDI-Public: 08717648162657
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 11/07/2020
• Device Catalogue Number: 1074400-23
• Device Lot Number: 7110241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1