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

Catalog Number 1125300-12

Device Problems Difficult To Position (1467); Failure to Advance (2524)

Patient Problem Intimal Dissection (1333)

Event Date 07/10/2017

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.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the reported patient effect of dissection is listed in the xience alpine everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.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 mildly calcified, restenosed lesion in the mid left anterior descending (lad) coronary artery.An attempt was made to cross a restenosed lesion with a 3.0x12mm rx xience alpine stent delivery system (sds), but the sds failed to cross due to interaction with the guiding catheter and another previously implanted stent; not due to patient anatomy.The sds was withdrawn without resistance and there was no damage caused to the previously implanted stent.There were no other device issues noted, however, a dissection occurred due to the failure to cross.The lad dissection and stenosis were successfully treated with balloon angioplasty with an unspecified 3.0x12mm balloon followed by placement of an unspecified stent.There was no occurrence of a clinically significant delay.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: 6745802
• MDR Text Key: 81113352
• Report Number: 2024168-2017-06226
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199332
• UDI-Public: 08717648199332
• 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: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2019
• Device Catalogue Number: 1125300-12
• Device Lot Number: 6092941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 97