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

Catalog Number 1011710-15

Device Problem Physical Resistance (2578)

Patient Problem Intimal Dissection (1333)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.The investigation determined an interaction with the calcified anatomy contributed to the resistance during advancement.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 of the reported lot did not indicate a lot specific quality issue.The reported patient effect of dissection is listed in the xience prime everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures; however a conclusive cause was unable to be determined for the patient effect.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a de novo lesion in the mildly tortuous, mildly calcified mid left anterior descending (lad) coronary artery.A 3.50 x 15 mm xience prime stent delivery system (sds) was selected for the procedure.The sds was advanced to the lesion with resistance, but it crossed and the stent was deployed with no issues noted.Following deployment of the stent implant a dissection was observed.A 3.50 x 15 mm xience pro stent implant was used to successfully cover the dissection.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: 6249708
• MDR Text Key: 64761385
• Report Number: 2024168-2017-00425
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648123696
• UDI-Public: (01)08717648123696(17)181216(10)5121141
• 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: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2018
• Device Catalogue Number: 1011710-15
• Device Lot Number: 5121141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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