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

Catalog Number 1120300-38

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.It is unknown if the device is returning for analysis.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat an unspecified coronary artery.A 3.0 x 38 mm xience alpine stent delivery system was used; however, the hypotube was noted to be separated.No additional information was provided.

Manufacturer Narrative

Device codes: 2920 labeled 2889 labeled.Internal file number (b)(4).B3 correction: date of event was estimated as (b)(6) 2018 on the initial report; however, based on new information received the correct date is (b)(6) 2018.Device codes 1467 and 2889 were added.Evaluation summary: the device was returned for analysis.The reported kinked shaft was confirmed.The reported detachment of a device component was not confirmed.The reported difficulty to position could not be replicated in a testing environment as it was 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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported detachment of a device component as no detachment was identified during return device analysis.It should be noted, multiple attempts were made to ensure the correct device was returned for analysis with no response from the account.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report, additional information was received.The lesion was moderately calcified and a kink was noted on the hypotube.Additionally, there was a hypotube separation that occurred inside the anatomy and was simply withdrawn from the anatomy.The device met resistance during advancement.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
• MDR Report Key: 8020631
• MDR Text Key: 125641451
• Report Number: 2024168-2018-08283
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2020
• Device Catalogue Number: 1120300-38
• Device Lot Number: 7101341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1