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

Catalog Number 1070300-48

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The ptca priority pack accessory kit referenced is being filed under a separate medwatch mfr number.

Event Description

It was reported that when trying to pass the 3.0x48 mm rx xience xpedition stent delivery system (sds) through the rotating hemostatic valve (rhv) from the priority pack accessory kit, the stent got stuck inside the rhv and during removal of the sds the stent dislodged from the balloon in the rhv.The rhv was replaced with a new rhv and a new same size rx xience xpedition stent was used to treat the target lesion.There was no adverse patient effect as the device did not contact the patient.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The stent dislodgement was unable to be confirmed.The difficult to insert/remove the device could not be replicated in a testing environment due to the condition of the returned device.Based on a visual and dimensional 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 determined the reported difficulties 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.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.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 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: 5039515
• MDR Text Key: 24584941
• Report Number: 2024168-2015-04951
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2018
• Device Catalogue Number: 1070300-48
• Device Lot Number: 5011941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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