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

Catalog Number 1070225-18

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/03/2014

Event Type  Injury  

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/review of the complaint database revealed no similar incidents reported for device damaged by another device or stent damage from this lot.Based on the reviewed information, no product deficiency was identified.

Event Description

It was reported that on (b)(6) 2014, the procedure was to treat a 95% stenosed lesion in the distal right coronary artery (rca).After placement of a 6-french non-abbott guiding catheter, the whisper extra-support (es) guide wire was placed, followed by placement of a balanced middle weight (bmw) universal ii buddy guide wire.The 2.25x18mm xience xpedition stent implant was successfully deployed and post-dilatation was performed with a 3.0x06mm non-abbott balloon dilatation catheter (bdc).At the end of the procedure, the bmw universal ii buddy wire was removed without issue; however, during removal of the whisper es guide wire resistance was met with the deployed xience xpedition stent implant.After removal of the whisper es guide wire, the deployed xience xpedition stent implant was noted to be longitudinally compressed partially into health tissue and the distal portion of the lesion in not covered.No additional treatment was performed.There was no reported adverse patient sequela; however, the patient was kept hospitalized for observation until (b)(6) 2014.There was no additional information provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent implant remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The hi-torque whisper referenced is being filed under a separate medwatch mfr number.

• Brand Name: XIENCE XPEDITION 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: 4353738
• MDR Text Key: 12642463
• Report Number: 2024168-2014-08404
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2016
• Device Catalogue Number: 1070225-18
• Device Lot Number: 4061641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2014
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2015
• 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
• Treatment: GUIDE WIRE: WHISPERGUIDE CATHETER: MEDTRONIC FR4
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 75