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

Catalog Number 1128250-23

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Stenosis (2263)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: 3.0x23mm and 4.0x18mm xience pro stents; 6f guide catheter.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 other incidents from this lot.It should be noted that the reported patient effect of stenosis is listed in the xience pro a everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional two xience proa devices referenced are being filed under separate medwatch reports.

Event Description

It was reported that on (b)(6) 2019, a 2.5x23mm, 3.0x23mm, and 4.0x18mm xience pro stents were implanted in the right coronary artery lesion.Stent under-expansion was noted for all three stents, requiring additional post-dilatation with a balloon catheter.Post-procedure, there was 0% diameter stenosis.On (b)(6) 2019, in-stent restenosis was observed in the 2.5x23mm xience pro stent.Another stent was implanted as treatment.The event resolved without sequela.No additional information was provided regarding this issue.

• Brand Name: XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
• 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: 8519307
• MDR Text Key: 142103806
• Report Number: 2024168-2019-02968
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/16/2019

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: 01/17/2021
• Device Catalogue Number: 1128250-23
• Device Lot Number: 8010841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 100