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

Catalog Number 1120250-15

Device Problem Difficult To Position (1467)

Patient Problem Intimal Dissection (1333)

Event Date 05/11/2017

Event Type  Injury  

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.The investigation determined the reported difficult to position appears to be related to circumstances of the procedure as it is likely that as the 2.5x18mm and a 2.0x8mm xience alpine stents were advanced interaction with the deployed 2.5x15mm xience alpine stent resulted in the reported difficulty to position.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, dissection is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.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 from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a lesion in the ostial right coronary artery.A 2.5x15mm xience alpine stent was implanted and post-dilatation was performed with a 2.75x12mm nc trek balloon dilatation catheter.A dissection was observed distal to the implanted stent and part of the dissection was treated with a 2.25x15mm xience.A 2.5x18mm and a 2.0x8mm xience alpine stents were advanced; however, they were unable to get through the implanted 2.5x15mm stent.An attempt to cross using a buddy wire was made; however, this too failed.There was no adverse patient sequela.There was no clinically significant delay in the procedure.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: 6594074
• MDR Text Key: 76057485
• Report Number: 2024168-2017-04544
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648205514
• UDI-Public: (01)08717648205514(17)200122(10)7011241
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2020
• Device Catalogue Number: 1120250-15
• Device Lot Number: 7011241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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
• Treatment: DILATATION BALLOON: 2.75X12MM NC TREK
• Patient Outcome(s): Required Intervention