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

Catalog Number 1011711-33

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a narrow and concentric right coronary artery.During preparation, the protective sheath could not be removed from a 4.0 x 33 mm xience prime stent delivery system.Then, the stent became damaged after the protective sheath was pulled forcibly.Additionally, the tip was separated from the device.Therefore, another 4.0 x 33 mm xience prime stent delivery system was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported tip detachment was confirmed and the reported material deformation (stent damage) was not confirmed.The reported difficulty to remove could not be replicated in a testing environment as the sheath and stylet were already removed.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.It should be noted that the xience prime everolimus eluting coronary stent system instruction for use states: remove the product mandrel and protective stent sheath by grasping the catheter just proximal to the stent (at the proximal balloon bond site), and with the other hand, grasp the stent protector and gently remove distally.If unusual resistance is felt during product mandrel and stent sheath removal, do not use this product and replace with another.Additionally, the investigation was unable to determine a conclusive cause for the reported material deformation (stent damage) as no material deformation was noted during returned device analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PRIME LL 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: 7121702
• MDR Text Key: 95194944
• Report Number: 2024168-2017-09782
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110019
• 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,Followup
• Report Date: 01/30/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2020
• Device Catalogue Number: 1011711-33
• Device Lot Number: 7033041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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