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

Catalog Number 1125250-18

Device Problems Difficult to Insert (1316); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported difficulties inserting the sds however the stent damage and dislodgement appear to be related to circumstances of the procedure.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 reported from this lot.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that during a coronary procedure, the 2.5 x 18 mm xience alpine stent delivery system was inserted into the non-abbott hemostasis valve and resistance was noted.The stent delivery system was removed without resistance; however, it was noted that the stent was not on the delivery system balloon.The dislodged stent remained on the guide wire, inside the hemostasis valve.The guide wire and stent were removed without difficulty and the stent was noted to be crushed on the guide wire.A second same size xience alpine was used without issue.There was no adverse patient effect and no clinically significant delay.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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6286785
• MDR Text Key: 66133842
• Report Number: 2024168-2017-00769
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199172
• UDI-Public: (01)08717648199172(17)191114(10)6110161
• 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: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2019
• Device Catalogue Number: 1125250-18
• Device Lot Number: 6110161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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
• Patient Age: 75 YR