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

Catalog Number 1128250-23

Device Problem Defective Device (2588)

Patient Problem Intimal Dissection (1333)

Event Date 11/30/2018

Event Type  Injury  

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 evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The xience proa is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.

Event Description

It was reported that the procedure was performed to treat a lesion in the mid left anterior descending artery.A 2.5x23mm xience proa stent was deployed at 12 atmospheres (atm) to treat a stenosis.It was then decided to deploy a 2.75x18mm xience proa stent at 12 atm proximal to the first one.During the angiogram, it appears that the 2.75x18mm had a smaller diameter than the 2.5x23mm.It was thought that the balloon of the 2.5x23mm stent was bigger and therefore also the diameter was bigger than desired.The 2.5x23mm balloon looked like it inflated to a 3.0mm.A dissection at the position of the 2.5x23 mm stent was noted.A non-abbott stent was deployed to successfully cover the dissection.There was no reported device issue with the 2.75x18 mm stent.The patient is doing well.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the device was returned for analysis.The reported defective item was not confirmed.The cine of the event was received and reviewed by an abbott clinical specialist who concluded the following: the reviewer concluded the stent placed in the mid lad (2.5 x 23 mm) did not appear larger in diameter than the proximal stent (2.75 x 18 mm).The visualization in some of the images was poor, but review of several images did not show the variation in diameter described within the incident report.The actual diameter of the stent would require measurement with the fluoroscopy system at the site.The confirmation of a miss-sized balloon of the delivery system would require confirmation by the returned goods lab.The investigation was unable to determine a conclusive cause for the reported defective item (large diameter) as no issue was identified during return device analysis.The reported patient effect of dissection is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect 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.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 8181614
• MDR Text Key: 130922554
• Report Number: 2024168-2018-09890
• 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: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2021
• Device Catalogue Number: 1128250-23
• Device Lot Number: 8041741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: 2.75X18MM XIENCE PROA; STENT: 2.75X18MM XIENCE PROA
• Patient Outcome(s): Required Intervention