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

Catalog Number 1011710-12

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the coronary circumflex.A 3.5 x12 mm xience prime stent delivery system (sds) was unpackaged, the box was labeled 3.5 x12 mm xience prime sds.The stent was implanted and under angiography it was confirmed the stent was actually a 3.5 x 15 mm and not a 3.5 x12 mm as labeled on the box.The pouch was labeled 3.5x15mm.There were no adverse patient effects and no clinically significant delay in 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 from this lot.A conclusive cause for the reported device markings issue cannot be determined.Upon investigation, it was determined that the respective lots were manufactured approximately four days apart on separate manufacturing lines at abbott vascular clonmel which indicates the two units involved in this complaint never came into contact with one another during production or packaging.Additionally, both lots were sold to the account.In this case, it is possible that the placement of the 3.50 x 15 mm xience prime stent delivery system (sds) in the chipboard box for a 3.50 x 12 mm xience prime sds occurred at the hospital; however, this cannot be confirmed.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: XIENCE PRIME 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
• MDR Report Key: 7711469
• MDR Text Key: 114756575
• Report Number: 2024168-2018-05682
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2018
• Device Catalogue Number: 1011710-12
• Device Lot Number: 5121441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1