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

Catalog Number 1011707-28

Device Problems Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2014

Event Type  malfunction  

Event Description

It was reported that during unpackaging of the 2.5x28mm xience prime stent delivery system (sds), the stent implant was noted to have a flared strut and the sds was not used.There was no reported patient involvement and no reported clinically significant delay in the procedure.An unspecified sds was used to successfully complete the procedure.There was no additional information provided.The xience prime sds was returned with the shaft torn and separated.Follow-up information received from the account stated that no separation was reported during use of the device and that it must have occurred during shipping/packaging for return.Additionally, the xience prime sds was returned with a foreign material (string) in the inflation lumen.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The stent damage was not confirmed.However, there was foreign material (string) in the inflation lumen.Based on a visual inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances.A query/review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the reviewed information, no product deficiency was identified.

• Brand Name: XIENCE PRIME 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: 4190277
• MDR Text Key: 18543727
• Report Number: 2024168-2014-06860
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2015
• Device Catalogue Number: 1011707-28
• Device Lot Number: 112084X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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