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

Catalog Number 1011709-23

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a 90% stenosed, mildly calcified lesion in the heavily tortuous mid right coronary artery (rca) and a 95% stenosed, mildly calcified lesion in the proximal left anterior descending (lad) artery.Pre-dilatation was performed in the proximal lad with a 2.5x15mm unspecified balloon dilatation catheter (bdc) and pre-dilatation was performed in the mid rca with a 3.0x25mm unspecified bdc.The 3.0x23mm xience prime stent delivery system (sds) failed to cross the lesion in the lad reportedly due to interactions with the patient's anatomy.Additionally, resistance was met during withdrawal of the sds reportedly due to interactions with the patient's anatomy.A 2.75x23mm xience prime sds was used to successfully treat the lesion in the lad.The 2.75x38mm xience prime sds failed to cross the lesion in the rca reportedly due to interactions with the patient's anatomy.Additionally, resistance was met during withdrawal of the sds reportedly due to interactions with the patient's anatomy.A 2.75x38mm xience xpedition sds was used to successfully treat the lesion in the rca.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.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.The results of the query of similar incidents in the complaint handling database for this lot did not indicate a manufacturing issue.Based on the reviewed information, no product deficiency was identified.The 2.75x38mm xience prime referenced is being filed under a separate medwatch mfr number.

• 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: 4351425
• MDR Text Key: 21724761
• Report Number: 2024168-2014-08367
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2017
• Device Catalogue Number: 1011709-23
• Device Lot Number: 406054N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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
• Patient Age: 72 YR
• Patient Weight: 70