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

Catalog Number 1125250-38

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2018

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 difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guiding catheter during advancement causing the reported difficulty to position and subsequent material deformation (stent flare).The device was removed and interacted with the guiding catheter during retraction causing the reported difficulty to remove.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that the procedure was to treat a mildly tortuous, mildly calcified, 75% stenosed concentric lesion in the mid left anterior descending (lad) coronary artery.Pre-dilatation was performed with a 2.5x15 mm non-abbott device.A 2.5x38 mm xience alpine stent delivery system (sds) was advanced; however, resistance was noted with a 6 fr non-abbott guiding catheter before passing the insertion site of the vessel.The sds was removed independently from the patient anatomy; however, resistance was felt with the guiding catheter.The proximal end stent struts were noted to be flared.A new same size xience alpine sds was advanced using the same non-abbott guiding catheter to successfully complete the procedure.There was no reported adverse patient effects or a 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: 7534907
• MDR Text Key: 109113948
• Report Number: 2024168-2018-03818
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: 08717648199219
• 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,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2019
• Device Catalogue Number: 1125250-38
• Device Lot Number: 6072841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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