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

Catalog Number 1128300-33

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/20/2019

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 is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The xience proa is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that upon opening the package, there was no stent on the xience pro a delivery system.The device was not used and there was no patient involvement.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).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.The investigation was unable to determine a conclusive cause for the reported missing components (stent).Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: the customer cannot confirm the initial report, that the stent was missing upon opening the packaging and the device is not available for evaluation.No additional information was provided.

• 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
• MDR Report Key: 8685477
• MDR Text Key: 147615340
• Report Number: 2024168-2019-04565
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2021
• Device Catalogue Number: 1128300-33
• Device Lot Number: 8022041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1