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

Catalog Number 1011711-18

Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a non-tortuous and moderately calcified de novo lesion in the proximal left anterior descending artery.A 4.0x18mm xience prime stent delivery system (sds) was advanced to the lesion; however, failed to cross due to the calcification.A second attempt was made to advance the sds; however, failed again.Resistance with the anatomy was noted during withdrawal, the proximal shaft kinked and separated outside the patients anatomy.As no device crossed successfully, the procedure was completed and the patient was referred to surgery.The patient is doing well.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported kinked and separated shaft was confirmed.The reported difficulty to remove and failure to advance were unable to be replicated in a testing environment as they are based on operational circumstances.Reportedly, the xience prime device was re-inserted in a second attempt to cross the lesion; however, the device failed to cross again.The device was then removed against resistance from the anatomy.The sds was kinked and separated at the shaft during removal.The xience prime instructions for use states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged when retracting the undeployed stent back into the guiding catheter.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 as it is likely the device interacted with the non-tortuous and moderately calcified lesion causing the reported failure to advance.Resistance with the anatomy resulted in the reported difficulty to remove causing the reported shaft kink and separation.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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: 7169282
• MDR Text Key: 96815201
• Report Number: 2024168-2018-00117
• Device Sequence Number: 1
• Product Code: NIQ
• 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,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2019
• Device Catalogue Number: 1011711-18
• Device Lot Number: 6110941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 02/22/2018
• Supplement Dates FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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