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

Catalog Number 1009527-18

Device Problems Detachment Of Device Component (1104); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was to treat a de novo, eccentric lesion located in the moderately tortuous, distal circumflex.The 2.5 x 18 mm xience v stent delivery system (sds) failed to cross the lesion resulting in flared distal stent struts.Additionally, during manipulation of the sds the catheter shaft separated into two pieces.Another xience v sds was able to cross successfully.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was initially reported as returning for analysis; however, the device was not returned.The device was not returned for analysis.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 that as the stent delivery system was advanced, resistance was met with the moderately tortuous anatomy resulting in the reported failure to advance.Interaction with the moderately tortuous anatomy resulted in the reported material deformation (flared).Manipulation of the device ultimately resulted in the reported shaft detachment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

(b)(4).The device was reported as not returned; however, the device was returned for analysis.Evaluation summary: the device was returned for analysis.The reported material deformation and the reported detachment were able to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE V 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: 7102513
• MDR Text Key: 94948475
• Report Number: 2024168-2017-09553
• 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,Followup,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2018
• Device Catalogue Number: 1009527-18
• Device Lot Number: 6102841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2018
• 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