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

Model Number 1125400-15

Device Problems Collapse (1099); Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported collapse tip was unable to be confirmed; however, the stent was noted to be dislocated on the balloon.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.Due to the extent of the damage to the stent, it is unlikely that the protective sheath would have fit over the damage; therefore, the damage is not a pre-existing condition.It is likely that the reported tip collapse and noted stent dislocation was a result of inadvertent mishandling of the sds during unpackaging and/or during preparation and there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that the 4.0 x 15 mm xience alpine was noted to have a deformed tip upon removal from the dispenser hoop.There was no patient involvement and no clinically significant delay.Returned device analysis noted that the stent was stationary on the balloon, but was not between the markers.No additional information was provided.

• Brand Name: XIENCE ALPINE 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 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6676038
• MDR Text Key: 78782506
• Report Number: 2024168-2017-05509
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199615
• UDI-Public: (01)08717648199615(17)191005(10)6092741
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2019
• Device Model Number: 1125400-15
• Device Catalogue Number: 1125400-15
• Device Lot Number: 6092741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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