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); Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2017

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 received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that a 4.00 x 33 mm xience prime stent delivery system (sds) was selected for the procedure.Upon removal from the plastic hoop/coil the shaft of the sds was observed to be kinked.No damage to any of the packaging (chip board box, pouches, hoop/coil, etc.) had been observed prior to opening and the kink in the shaft was not observed prior to removing the sds from the plastic hoop/coil.The sds was not used in the procedure.A new unspecified sds was used to successfully complete the procedure.There was no reported clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.Returned device analysis found that there was a separation of the hypotube, 20.3 cm distal to strain relief tubing.Additionally, the sds was returned with contrast in the balloon and inflation lumen and blood in the guide wire lumen, indicating that the sds had been inserted on the guide wire.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported shaft kink and the reported shaft detachment were able to be confirmed.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

Subsequent to the previously filed 30-day medwatch report, additional information received indicates that the sds was inserted onto a guide wire and advanced into the patient's anatomy.During advancement, the sds met resistance resulting in a kink on the hypotube and the eventual separation of the hypotube into two pieces.

• 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: 6786414
• MDR Text Key: 82690444
• Report Number: 2024168-2017-06567
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2018
• Device Catalogue Number: 1011711-33
• Device Lot Number: 5111841
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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