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 Unstable (1667)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/12/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a tortuous and mildly calcified mid left anterior descending artery (lad) lesion.While deploying the xience prime stent, it was observed that the stent had partially moved from the stent delivery system (sds) balloon.Anticipating a complete stent dislodgement, the stent was deployed at a point only covering 40% of the lesion.A xience xpedition stent was implanted to treat the remaining part of the lesion.There was no adverse patient sequela.No additional information was 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 that would have contributed to the reported event.A query/review of the electronic complaint database revealed no other similar incidents reported for loose stents from this lot.Based on the reviewed information, no product deficiency was identified.

Manufacturer Narrative

(b)(4).Correction: it was initially reported that the device would not be returned for analysis; however, the device has been received for evaluation.Evaluation summary: the device was returned for analysis.The unstable/ loose stent was unable to be replicated in a testing environment as it was based on operational circumstances.Based on a visual inspection of the returned device, there is no indication of a product deficiency.

• 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: 3796910
• MDR Text Key: 4522849
• Report Number: 2024168-2014-02882
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2015
• Device Catalogue Number: 1011707-15
• Device Lot Number: 3010741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 79