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

Catalog Number 1125350-23

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913); Material Deformation (2976); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: rinato, sion blue, stent: resolute integrity (x3): 3.5x26, 3.0x26, and 3.0x22.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that during the procedure to treat a concentric, non-calcified, 75% stenosed, de novo, 20 mm-long lesion in the mildly tortuous, 3.5 mm diameter distal right coronary artery (rca), after deploying two non-abbott stents in the proximal through distal rca, a 3.5x23 rx xience alpine stent delivery system (sds) was advanced to the distal rca without issue, however, while attempting to position the stent, the distal part of the sds, it jumped abruptly; there was no attempt to deploy the stent.Upon withdrawal without difficulty, the proximal stent struts of the rx xience alpine were noted to be flared 180 degrees (almost mangled), but the stent was confirmed to be firmly crimped on the balloon.This xience alpine was not used in completing the procedure.A new xience alpine was successfully used to complete the procedure.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.The abbott vascular returned goods lab received the device and a visual inspection revealed the guide wire exit notch had a tear measuring 4.2 mm in length.Additional information received indicated that the site was not aware of the tear in the guide wire exit notch and does not know how it occurred.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis with the guide wire exit notch torn.Follow-up with the site was performed; however, the site was unaware when the damage may have occurred.The reported material deformation was able to be confirmed.The report that the device operates differently than expected (distal part of the stent delivery system(sds) jumped abruptly) was unable to be replicated in a testing environment as it was based on operational circumstances.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 did not indicate a lot specific quality issue.Additionally, the xience alpine everolimus eluting coronary stent system (eess), domestic instructions for use (ifu) states: although the safety and effectiveness of treating more than one lesion per coronary artery with xience alpine stents have not been established, if this is performed, place the stent in the distal lesion before the proximal lesion in order to minimize dislodgement risk incurred by traversing through deployed stents.The xience alpine, japan, instructions for use (ifu) is written in japanese; therefore the domestic xience alpine instructions for use (ifu) is referenced.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE ALPINE 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: 6010913
• MDR Text Key: 57098363
• Report Number: 2024168-2016-06748
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2018
• Device Catalogue Number: 1125350-23
• Device Lot Number: 5072741
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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