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

Catalog Number 1125275-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Prolapse (2475)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: guide wire: rinato, guide catheter: hyperion.The device was not returned for evaluation.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.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.The tenku rx is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a moderately tortuous, mildly calcified, concentric, and de novo first diagonal artery that was 90% stenosed.An unspecified xience alpine stent was implanted in the proximal left anterior descending artery when plaque shift occurred at the entrance of the first diagonal.A 1.5 x 12 mm rx tenku was being used to dilate the vessel when the balloon ruptured on the first inflation after 10 seconds at 6 atmospheres.A non-abbott balloon was successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.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: 6528647
• MDR Text Key: 73894185
• Report Number: 2024168-2017-03726
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199271
• UDI-Public: (01)08717648199271(17)191115(10)6110741
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2019
• Device Catalogue Number: 1125275-23
• Device Lot Number: 6110741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2017
• 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 Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 69