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

Catalog Number 1070275-23

Device Problems Detachment Of Device Component (1104); Material Separation (1562); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2017

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 was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the mid coronary that was heavily calcified, heavily tortuous and re-stenosed.The lesion was pre-dilated at 18-22 atmospheres.When the xience xpedition 2.75 x 23 mm stent delivery system was advanced through the diagonal branch, it did not track well and was replaced with a smaller stent delivery system that also did not reach the lesion.Balloon angioplasty was used to complete the procedure.Angiography revealed a good result after balloon angioplasty.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information can be provided.Device analysis revealed there was a hypotube separation.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported shaft detachment was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.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.Based on the information reviewed and analysis of the returned device, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the previously filed medwatch report, the following additional information was received: the physician confirmed that due to intense tortuosity and calcification, and despite the use of two guide wires for additional support after forcing the stent during advancement, there was a fracture of the stent delivery system, which was then replaced by another stent to successfully complete the procedure.

• Brand Name: XIENCE XPEDITION 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: 7260838
• MDR Text Key: 99943290
• Report Number: 2024168-2018-00965
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2018
• Device Catalogue Number: 1070275-23
• Device Lot Number: 5031141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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 Age: 77 YR