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

Catalog Number 1011707-18

Device Problem Physical Resistance (2578)

Patient Problem Intimal Dissection (1333)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The investigation determined the reported physical resistance appears to be related to circumstances of the procedure as it is likely that as the sds was advanced resistance was met with the heavily tortuous, moderately calcified anatomy resulting in the reported physical resistance.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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, dissection is listed in the xience prime everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a de novo lesion in the heavily tortuous, moderately calcified, distal posterior descending coronary artery.A 2.5 x 18 mm xience prime stent delivery system (sds) was advanced to the lesion with resistance felt, and crossed.The stent was successfully deployed at a pressure of 10 atmospheres and a 2.5 x 12 mm nc trek balloon dilatation catheter (bdc) was used for post-dilatation and was inflated to a pressure of 18 atmospheres.After post-dilatation a distal edge dissection was observed.In order to cover the dissection, another 2.5 x 18 mm xience prime stent was successfully implanted.There was no reported clinically significant delay in the procedure.No additional information was provided.

• 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
• 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: 6283533
• MDR Text Key: 65961437
• Report Number: 2024168-2017-00737
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648123467
• UDI-Public: (01)08717648123467(17)190306(10)6030141
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2019
• Device Catalogue Number: 1011707-18
• Device Lot Number: 6030141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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
• Treatment: DILATATION CATHETER: 2.5 X 12 MM NC TREK
• Patient Outcome(s): Required Intervention