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

Catalog Number 1011707-15

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in the circumflex.It was observed that 2.5 x 15 mm xience prime had a puncture in the distal portion of the shaft.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

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.

Event Description

Additional information received: the xience prime delivery system never entered the patient's anatomy.The puncture was observed while introducing the guide wire.A new xience prime stent was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The tear in the shaft was able to be confirmed.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 that would have contributed to the reported event.A query/review of the electronic complaint database revealed no other similar incidents reported for tears in the shaft from this lot.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: 4413061
• MDR Text Key: 5375990
• Report Number: 2024168-2015-00216
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2015
• Device Catalogue Number: 1011707-15
• Device Lot Number: 3041741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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