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

Catalog Number 1009527-15

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2012

Event Type  malfunction  

Event Description

It was reported that during a procedure to treat a de novo lesion in the left anterior descending artery with 70% stenosis, a 2.5x15 mm rx xience v stent delivery system (sds) was advanced and deployed.The stent was well apposed; however, the balloon was difficult to deflate and the deflation time was long.While the sds was being withdrawn, resistance was felt with the non-abbott guiding catheter.The sds was finally able to be withdrawn with the balloon deflated in the guiding catheter; however, the balloon refold was poor.Additionally, a 2.5x8 mm rx xience v sds was implanted during the procedure without issue.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated patient age as it was reported to be between 56-65 years.Estimated date of occurrence as it was reported to have occurred in (b)(6) 2012.Estimated date of angiogram.Estimated date of implant as it was reported to have been in (b)(6) 2012.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 that would have contributed to the reported event.A query of the electronic complaint database revealed no other similar incidents reported for deflation issues, difficult to remove from the guiding catheter, or balloon refold issues from this lot.Based on the reviewed information, no product deficiency was identified.

• Brand Name: XIENCE V 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: 4298267
• MDR Text Key: 5055703
• Report Number: 2024168-2014-07936
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P070015
• 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: 11/01/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2014
• Device Catalogue Number: 1009527-15
• Device Lot Number: 2051541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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
• Treatment: STENT: 2.5X8 MM RX XIENCE V
• Patient Age: 60 YR