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

Catalog Number 1076350-15

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4) 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.(b)(4).The xience prox is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.The device remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

Reportedly, a 3.50 x 15 mm xience prox stent was implanted after expiration.There was no reported clinically significant delay in the procedure and no reported adverse patient sequela.No additional information was provided.

Manufacturer Narrative

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 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 the reported information of use after expiration was use error.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XIENCE DRUG ELUTING CORONARY STENT
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9056899
• MDR Text Key: 158999789
• Report Number: 2024168-2019-11802
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Catalogue Number: 1076350-15
• Device Lot Number: 6072541
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1