MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1009529-28

Device Problems Difficult or Delayed Positioning (1157); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported movement of the stent during deployment; however, the difficulties crossing appear to be related to the calcified patient anatomy.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 reported from this lot.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a de novo lesion located in the distal left anterior descending (lad) artery with moderate tortuosity and mild calcification.A 3.0 x 28 mm xience v rx drug eluting stent (des) was advanced to the lesion and it crossed successfully; however, it was stated that the crossing was difficult when compared to other xience devices.During deployment of the stent implant, the stent implant moved from the intended lesion.Another xience v was deployed, overlapping the initial xience v stent implant, to treat the lesion.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.

• Brand Name: XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6240908
• MDR Text Key: 64977470
• Report Number: 2024168-2017-00298
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648062841
• UDI-Public: (01)08717648062841(17)170921(10)5091641
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2017
• Device Catalogue Number: 1009529-28
• Device Lot Number: 5091641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 65