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

Catalog Number 1076350-12

Device Problems Failure to Advance (2524); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The foreign material was able to be confirmed.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Based on a visual and dimensional inspection and chemical analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.

Event Description

It was reported that during a procedure to treat a lesion in the left anterior descending artery, a 3.5x12 mm rx xience prox stent delivery system (sds) was advanced but could not cross the lesion due to the patient anatomy.The sds was withdrawn from the patient anatomy and some kind of foreign material was stuck below the stent (looks like a thread) which was not noted before the failure to cross.Reportedly, the 3.5x12 mm rx xience prox sds was inspected and prepped per the instructions for use and the thread-like foreign material was not noted.A 3.5x15 mm rx xience prox sds was successfully implanted after pre-dilatation was performed with a 3.5x15 mm non-abbott balloon catheter.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The xience prox is currently not commercially available in the us.The product code and the pma# is based on the predicate device (xience xpedition) and is therefore similar to a device sold in the us.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• Brand Name: XIENCE PROX EVEROLIMUS ELUTING RX 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4116132
• MDR Text Key: 12359544
• Report Number: 2024168-2014-06180
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2017
• Device Catalogue Number: 1076350-12
• Device Lot Number: 4020641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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