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

Catalog Number 1011711-28

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) used after expiration date.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of dissection is listed in the xience prime everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effects of coronary stenting procedures.The product was not returned to abbott vascular for analysis therefore the expiration date on the specific product labels could not be confirmed.However, a review of the labels attached to the electronic lot history record for this lot was conducted and all labels indicated an expiration date (use by date) of 02 january 2021, which is 36 months from the date of manufacture (03 january 2018).However, it was reported the stent was implanted on (b)(6) 2021.It should be noted that the ifu states: note the product ¿use by¿ date.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

Event Description

It was reported that the procedure was to treat a mildly calcified, 95% stenosed, de novo lesion in the left circumflex (cx) artery.After pre-dilatation, a 4x28mm xience prime drug eluting stent (des) was implanted in the target lesion.After post-dilatation was performed with an nc balloon, it was noted that there was a distal edge dissection.Another xience prime des was implanted to treat the dissection and successfully complete the procedure.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Filed to add conclusion code 18.

Event Description

Subsequent to the previously filed medwatch reports, the following information was received: the correct event date is (b)(6) 2020.The device was not used after expiration.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of dissection is listed in the xience prime everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.B3, c4: date of event h6: device code - 2017 - removed.Device was not used after expiration.H6: conclusion code - 18 - removed.

• Brand Name: XIENCE PRIME 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: 11197941
• MDR Text Key: 227721161
• Report Number: 2024168-2021-00568
• 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,Followup
• Report Date: 01/22/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2021
• Device Catalogue Number: 1011711-28
• Device Lot Number: 7121941
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 01/19/2021; 01/22/2021
• Supplement Dates FDA Received: 01/19/2021; 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1.5X12 SC BALLOON; NC BALLOON 4.0X8
• Patient Outcome(s): Required Intervention