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

Catalog Number 1125350-38

Device Problems Inflation Problem (1310); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

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.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 physical resistance appears to be related to circumstances of the procedure as it is likely the stent delivery system interacted with the difficult anatomy during advancement causing the reported physical resistance.Additionally, the investigation was unable to determine a conclusive cause for the reported inflation issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that this was a procedure to treat a chronic total occlusion in the left anterior descending coronary artery (lad).The xience alpine stent delivery system was advanced to the lesion with more resistance than average due to anatomy.Once at the lesion site, the xience alpine balloon failed to inflate.The undeployed stent remained in place on the delivery system and the device was removed from the anatomy without issue.A non-abbott device was used in replacement.There were no adverse patient effects and there was no clinically significant procedural delay.There was no additional information provided regarding this issue.

• 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: 7423694
• MDR Text Key: 105398045
• Report Number: 2024168-2018-02690
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199578
• UDI-Public: 08717648199578
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Catalogue Number: 1125350-38
• Device Lot Number: 7071841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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