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

Catalog Number 1011710-18

Device Problems Difficult or Delayed Positioning (1157); Kinked (1339); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a heavily calcified chronic total occlusion of the distal circumflex artery that was 100% stenosed.The radial approach was taken.Pre-dilatation was done with an unspecified balloon dilatation catheter.Then, a 3.5 x 18 mm xience prime stent delivery system (sds) was advanced and met initial resistance with the anatomy.A kink was also noted on the distal shaft.Then during deployment of the stent at 10 atmospheres, since the sds met initial resistance with the anatomy, the stent deployed partially in the lesion and partially in healthy tissue.Therefore, the stent was post-dilated with an unspecified balloon catheter per normal procedure in order to be fully apposed in the vessel and lesion.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

(b)(4).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 incidents from this lot.It should be noted that the xience prime everolimus eluting coronary stent system instructions for use states: do not use if any defects are noted.In this case the ifu deviation did not contribute to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Additionally, the difficult anatomy interacted with the device during deployment causing the reported difficulty to deploy.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PRIME 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
• MDR Report Key: 7448676
• MDR Text Key: 106162695
• Report Number: 2024168-2018-02950
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Catalogue Number: 1011710-18
• Device Lot Number: 7080441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1