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

Catalog Number 1070300-38

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

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 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.It should be noted that the xience xpedition everolimus eluting coronary stent system instructions for use states: applying excessive force to the delivery system can potentially result in loss or damage to the stent and/or delivery system components.The investigation determined that the reported shaft kink and shaft detachment appear to be related to the use error; however, the reported failure to advance appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was to treat a mildly tortuous and moderately calcified de novo distal right coronary artery that was 90% stenosed.An unspecified sion guide wire crossed the lesion, and pre-dilatation was done with a 2.5 x 20 mm trek balloon.Then, an attempt was made to cross a 3.0 x 38 mm xience xpedition stent; however, it failed to cross the lesion due to the anatomy.Additionally, the proximal shaft of the stent delivery catheter became kinked when force was used to advance the device in the mid right coronary artery.Therefore, the device was removed; however, the proximal shaft separated once it was outside the anatomy.A 3.0 x 33 mm xience xpedition stent was then implanted, and a 3.5 x 12 mm xience xpedition stent was also implanted to overlap the 3.0 x 33 mm xience xpedition stent to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• 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: 7060963
• MDR Text Key: 93309011
• Report Number: 2024168-2017-09173
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 11/27/2017

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: 03/24/2018
• Device Catalogue Number: 1070300-38
• Device Lot Number: 5031341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 72 YR
• Patient Weight: 90