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

Catalog Number 1011710-18

Device Problems Collapse (1099); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2015

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in an unspecified artery.The 3.5x18mm xience prime stent delivery system (sds) was advanced to the target lesion and the stent implant was deployed without reported issue.However, during withdrawal of the sds, resistance was met with the 5-french guiding catheter.After withdrawal, the sds balloon was noted to be damaged.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.The procedure was successfully completed.There was no additional information provided.

Manufacturer Narrative

(b)(4).Date of event has been estimated.Date of relevant tests/laboratory data has been estimated.Date implanted has been estimated.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a 70% stenosed lesion in the diagonal artery.The 3.5x18mm xience prime stent delivery system (sds) was advanced to the target lesion and the stent implant was deployed without reported issue.However, during withdrawal of the sds, resistance was met with the 5-french guiding catheter; thus, both devices were removed as a single unit.After withdrawal, the sds balloon was noted to be wrinkled.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.The procedure was successfully completed.There was no additional information provided.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances.A query of the electronic complaint database revealed no other incidents reported for difficult to remove or balloon damage 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 of the device.

• 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: 4812039
• MDR Text Key: 5891904
• Report Number: 2024168-2015-03104
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2016
• Device Catalogue Number: 1011710-18
• Device Lot Number: 304254A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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