MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1070275-48

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

Patient Problem Vomiting (2144)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (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 heavily tortuous, heavily calcified, and de novo lesion located in the proximal circumflex artery that was 95% stenosed.Pre-dilatation was performed with a 1.5 x 6 mm, 2.5 x 8 mm, and a 2.75 x 18 mm unspecified balloon catheters.A 2.75 x 48 mm xience xpedition stent could not cross the lesion due to the anatomy, and when the stent delivery system was removed, the shaft separated inside the patient.The separated portion was simply pulled out by the proximal part of the shaft.Another 2.75 x 48 mm xience xpediton was used, but failed to cross due to the anatomy.The procedure was successfully completed with a 2.75 x 18 mm and a 2.75 x 28 mm xience alpine stents.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).A visual and dimensional inspection were 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.

• Brand Name: XIENCE XPEDITION 48 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: 7342074
• MDR Text Key: 102586945
• Report Number: 2024168-2018-01862
• 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: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2020
• Device Catalogue Number: 1070275-48
• Device Lot Number: 7081741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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