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

Catalog Number 1076250-18

Device Problems Detachment Of Device Component (1104); Failure to Advance (2524); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis with the distal shaft torn at the guide wire exit notch and the hypotube separated.However, the failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Furthermore, it is likely that the torn distal shaft at the guide wire exit notch, bent hypotube and hypotube separation noted during returned analysis is due to further handling and packaging of the device to return to abbott vascular.Based on the visual and dimensional analysis of the returned stent implant, 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.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.(b)(4).The xience prox is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that four xience prox stents (2.5 x 8 mm, a 2.5 x 23 mm and two 2.5 x 18 mm) were used during the procedure.Three of the stent delivery systems did not cross the lesion due to the anatomy.The other xience prox was found to be defective after unpacking.The device was not used.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.Qat analysis revealed there were bent struts on the proximal end of the stent implant, the distal shaft was torn at the guide wire exit notch and the hypotube was separated.

• Brand Name: XIENCE PROX 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: 5178065
• MDR Text Key: 29801979
• Report Number: 2024168-2015-06352
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2018
• Device Catalogue Number: 1076250-18
• Device Lot Number: 5040741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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