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

Catalog Number 1074400-23

Device Problems Difficult to Remove (1528); Unstable (1667); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

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 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 the mid right coronary artery (rca) that did not have any tortuosity or calcification.Pre-dilatation was performed with an unspecified 4.0 x 15 mm compliant balloon dilatation catheter.A 4.0 x 23 mm xience xpedition stent delivery system (sds) was then advanced to the lesion and did not meet any resistance.However, the stent was assessed to be too short to cover the lesion.Therefore, there was an attempt to remove the sds; however, the sds met resistance with a 6 fr non-abbott guiding catheter.The distal part of the stent moved backwards from the sds at the tip of the guiding catheter, and some of the proximal stent struts overlapped each other.The stent remained crimped on the sds balloon.An unspecified guide wire was then removed and the sds and the guiding catheter were removed together as a single unit to avoid stent displacement.Then, a 4.0 x 28 mm unspecified xience stent was implanted to successfully complete the procedure.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 was performed on the returned device.The reported material deformation was confirmed.The reported unstable stent was not confirmed.The reported difficult to remove could not be tested due to the condition of the returned device (stent).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.The investigation was unable to determine a conclusive cause for the reported unstable stent; however, the reported difficult to remove and material deformation appear to be related to circumstances of the procedure.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: 7437294
• MDR Text Key: 105930572
• Report Number: 2024168-2018-02840
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2020
• Device Catalogue Number: 1074400-23
• Device Lot Number: 7110241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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