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

Catalog Number 1070350-15

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a 100% stenosed mid left anterior descending (lad) artery.Two 2.5 x 12 mm non-abbott balloon catheters were used for pre-dilatation of two lesions in the lad.A 3.0 x 18 mm xience xpedition stent was deployed in the mid lad.A 3.5 x 15 mm xience xpedition stent was deployed proximal to the first stent.When removing the stent delivery system, it could not be pulled back into the guiding catheter.The balloon was re-inflated and deflated and it still could not be pulled into the guiding catheter so the entire system was removed as single unit.The balloon had not fully deflated and appeared deformed.Outside the anatomy the delivery catheter could not be removed without force.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).The cine of the event was received and reviewed by an abbott clinical specialist who concluded the following: the reported inability to fully deflate the balloon of the stent delivery system cannot be confirmed via these images.The inflated balloon is not shown post removal from the proximal stent in the left anterior descending coronary artery (lad), left main, or the right femoral artery.The stent that is deployed in the proximal lad has a good appearance and does not exhibit signs of damage that can be detected through the images provided.The device was returned for analysis.The deflation issue and difficulty removing the stent delivery system (sds) were unable to be confirmed however the wrinkled balloon was able to be confirmed.Based on a visual, dimensional, and functional inspection of the returned device, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported deflation issue however the difficulty removing the sds and wrinkled balloon appear to be related to circumstances of the procedure.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 the design, manufacture, or labeling of the device.

• 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: 5291062
• MDR Text Key: 33875194
• Report Number: 2024168-2015-07504
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2018
• Device Catalogue Number: 1070350-15
• Device Lot Number: 5071541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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