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

Catalog Number 1125225-18

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a procedure of the left anterior descending (lad) bifurcation, the 2.25 x 18 mm xience alpine stent delivery system (sds) was advanced, but could not cross due to the guide wires being wrapped in the vessel.During removal, the sds met resistance with an unspecified guide wire.Outside the anatomy stent strut damage was noted.A different xience alpine was used in the procedure.There was no reported adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: (b)(4).

Manufacturer Narrative

(b)(4).Visual, dimensional and functional inspections were performed on the returned device.The reported material deformation (stent damage) was confirmed.The reported difficulty to position and difficulty to remove were unable to be confirmed as they were based on 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.The investigation determined the reported difficult to position, difficult to remove and material deformation appear to be related to circumstances of the procedure and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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: 7003474
• MDR Text Key: 92195458
• Report Number: 2024168-2017-08697
• Device Sequence Number: 1
• Product Code: NIQ
• 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,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2020
• Device Catalogue Number: 1125225-18
• Device Lot Number: 7051061
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 11/14/2017; 11/28/2017
• Supplement Dates FDA Received: 11/20/2017; 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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: 68 YR