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

Catalog Number 1074350-28

Device Problems Difficult to Remove (1528); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2014

Event Type  malfunction  

Event Description

It was reported that during preparation, the stent dislodged prior to use for a 3.5x28 mm rx xience xpedition stent delivery system (sds).When the protective sheath was removed, resistance was felt and the stent implant was found to be shifted/moved.It is unknown at what point during prep the stent dislodgement occurred.The device was not used and there was no patient involvement.A new 3.5 mm xience xpedition sds was used.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The stent dislodgement was able to be confirmed.The difficulties removing the protective sheath and loose stent were unable to be replicated in a testing environment as the sds was not returned.Based on a visual and dimensional 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 electronic complaint database revealed no other similar incidents reported for difficult to remove the protective sheath or loose/dislodged stent from this lot.Based on the reviewed information, no product deficiency was identified.

• 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: 4232690
• MDR Text Key: 5072264
• Report Number: 2024168-2014-07262
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2016
• Device Catalogue Number: 1074350-28
• Device Lot Number: 4061942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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