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

Catalog Number 1017300-18

Device Problem Expulsion (2933)

Patient Problem Intimal Dissection (1333)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The xience pro device is currently not commercially available in the us; however, it is similar to a device sold in the us.There was no reported device malfunction and the product was not returned.Dissection is listed in the xience pro everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.Although a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.

Event Description

It was reported that the procedure was to treat a de novo lesion located in the mid right coronary artery (rca) that was mildly tortuous and mildly calcified.The lesion was pre-dilated with a non-specified balloon catheter.When the xience pro 3.0 x 18 mm stent was deployed, a dissection was observed at the distal end of the lesion.Another xience pro was used as treatment.There was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE PRO 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 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: 5399819
• MDR Text Key: 37179489
• Report Number: 2024168-2016-00536
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P070015
• 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
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2017
• Device Catalogue Number: 1017300-18
• Device Lot Number: 5071641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention