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

Catalog Number 1125350-15

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The other device referenced in describe event or problem and concomitant medical products is being filed under a separate medwatch report.

Event Description

It was reported that during the procedure to treat a target lesion in the proximal right coronary artery, the balance middleweight (bmw) guide wire was advanced and the 3.5 x 15 mm xience alpine stent delivery system was advanced over the guide wire; however, resistance was felt and the stent delivery system was removed without resistance.The second 3.5 x 15 mm xience alpine stent delivery system was advanced and resistance was also felt during advancement of this device.The second xience alpine could not be removed from the guide wire and both devices were removed from the patient anatomy as a single unit.There was no adverse patient effect and no clinically significant delay.The procedure was completed using a new guide wire and implantation of three stents.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.Visual and functional inspections were performed on the returned device.The difficult to position and remove the guide wire were confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial report, additional information was received, which indicates that resistance was felt during advancement of the 3.5 x 15 mm xience alpine stent delivery system over the bmw guide wire.The stent delivery system could not be removed from the guide wire and both devices were removed from the patient anatomy as a single unit.There was no adverse patient effect.No additional information was provided.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.Visual and functional inspections were performed on the returned device.The difficult to position and remove the guide wire was confirmed.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 of the reported lot did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the final report, additional information was received, indicating that the first 3.5 x 15 mm xience alpine stent was deployed at the target lesion; however, during removal of the stent delivery system, resistance was felt with the guide wire and the devices were removed as a single unit.This same issue occurred with the second 3.5 x 15 mm xience alpine stent; the stent was deployed at the target lesion, but during removal of the stent delivery system, resistance was felt with the guide wire and the devices were removed as a single unit.There was no adverse patient effect.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: 6093198
• MDR Text Key: 59874680
• Report Number: 2024168-2016-07837
• 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,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2018
• Device Catalogue Number: 1125350-15
• Device Lot Number: 5050541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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
• Treatment: GUIDE WIRE: BALANCE MIDDLEWEIGHT
• Patient Outcome(s): Other
• Patient Age: 78 YR