MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1011706-28

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2020

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that when opening the 2.25x28mm xience prime drug eluting stent (des) for an unspecified procedure, it was found to contain a 2.75x28mm xience prime des inside.The device was not used, and was replaced with a new xience prime des to successfully complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initially filed report, additional information was received as follows: the box was completely sealed and was not opened before.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported device markings / labelling problem was able to be confirmed.Additionally, it was noted that there were no visible left-over adhesive markings noted on the chipboard box.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 similar incidents from this lot.The lot history record (lhr) for the rx xience prime 2.25 x 28 lot noted that the lot was manufactured and packaged in clonmel suite 2 line 4 on 20 may 2019.Whereas the rx xience prime 2.75 x 28 lot was manufactured and packaged in clonmel suite 2 line 4 on 7 may 2019.There was no rework/repackaging performed on either lot.Therefore, this information indicates that the two lots involved in this complaint never came into contact with one another during production or rework/repackaging.Furthermore, a query of the system indicated that units from both lots were sent to the account.Thus, in review of the noted information, this suggests that a potential mix-up occurred at the account and/or at the hospital.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that a mix-up of device packaging at the account and/or at the hospital.A cause for the no visible left-over adhesive markings noted on the chipboard box cannot be determined.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.D4: lot number, catalog number, expiration date, udi #: changed to match the packaging information h4: manufacture date.

• Brand Name: XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10832775
• MDR Text Key: 218222224
• Report Number: 2024168-2020-09463
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2022
• Device Catalogue Number: 1011706-28
• Device Lot Number: 9051641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1