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 Remove (1528); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the proximal right coronary artery (rca).Pre-dilatation was performed.The 3.0 x 48 xience xpedition stent was deployed in the proximal to mid rca and confirmed to be fully apposed.The 2.25 x 12 mm xience prime stent delivery system (sds) was then advanced and the stent was deployed distally; however, during removal of the sds, there was interaction with the deployed stents and both stents were pulled into the catheter by the sds.Two new stents were used to treat the lesions.No additional information was provided.

Manufacturer Narrative

(b)(4).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.The additional xience prime referenced is being filed under a separate medwatch report.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The device damaged by another device was able to be confirmed.The difficult to remove could not be replicated in a testing environment as it was based on operational circumstances.Based on a visual 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.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint database revealed no other similar incidents reported for difficult to remove or device damaged by another device 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.

• 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4353371
• MDR Text Key: 5146111
• Report Number: 2024168-2014-08399
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2017
• Device Catalogue Number: 1070300-48
• Device Lot Number: 4081441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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
• Treatment: STENT: 2.25 X 12 MM XIENCE PRIME
• Patient Outcome(s): Required Intervention