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

Catalog Number 1076400-12

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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 prox device 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 the procedure was to treat a moderately tortuous and moderately calcified mid ramus intermedius artery.An unspecified guide wire was advanced to the lesion, and pre-dilatation was performed with an unspecified balloon catheter.A 4.0 x 12 mm xience prox stent delivery system (sds) was then used.The balloon was inflated; however, there was difficulty in deploying the stent at first.The balloon was then inflated five times at 23 atmospheres and the stent was implanted; it was well apposed to the vessel.However, the stent delivery balloon could not be removed from the stent during removal.Therefore, the balloon was inflated again and then fully deflated.The sds was then able to be removed from the stent.There were no adverse patient effects 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 difficulty to deploy could not be confirmed as the stent was not returned for analysis.The reported difficulty to remove the device was unable to be replicated in a testing environment as it was based on operational circumstances.It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use, states: note: do not exceed the labeled rated burst pressure (rbp).In this case, it does not appear the ifu deviation contributed to the reported difficulties.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.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy.The reported difficulty to remove appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PROX EVEROLIMUS ELUTING RX 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: 8497855
• MDR Text Key: 141450693
• Report Number: 2024168-2019-02758
• 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: 05/20/2019

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: 09/25/2020
• Device Catalogue Number: 1076400-12
• Device Lot Number: 7091541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1