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

Catalog Number 1009529-18

Device Problem Unstable (1667)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/17/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a mildly tortuous, mildly calcified and 90% stenosed mid left anterior descending artery.After pre-dilatation, a 3.0 x 18 mm xience v stent delivery system was being advanced to the lesion when the physician felt the stent had become loose on the balloon.The stent was implanted in healthy tissue proximal to the lesion site so it could not dislodge from the balloon.The procedure was stopped without treating the lesion.There was no clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The unstable/loose stent was unable to be confirmed as it was deployed in the patient anatomy.Based on a visual and functional 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 of the complaint database revealed no other similar incidents reported for unstable/loose stent 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: 4081963
• MDR Text Key: 4897889
• Report Number: 2024168-2014-05818
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P070015
• 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: 08/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2015
• Device Catalogue Number: 1009529-18
• Device Lot Number: 3041141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 75