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

Catalog Number 1128300-23

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

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: 2.5x23mm 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.The investigation was unable to determine a conclusive cause for the reported difficulty to position.Additionally, the reported treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience proa is currently not commercially available in the u.S; however, it is similar to a device sold in the us.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: 8519476
• MDR Text Key: 142108594
• Report Number: 2024168-2019-02971
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648226694
• UDI-Public: 8717648226694
• 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

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Catalogue Number: 1128300-23
• Device Lot Number: 8102441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 100