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

Catalog Number 1076350-33

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additonal 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, mildly calcified mid right coronary artery that was 90% stenosed.The lesion had been pre-dilated.A 3.50 x 33mm xience prox stent delivery system attempted to get to the lesion, but was at first unsuccessful.A non-abbott guiding catheter was used to facilitate deployment.The stent was deployed and inflated at 16 atmospheres.Thereafter, the stent balloon would not deflate.After several attempts to deflate the balloon holding negative 30 seconds to several minutes, it was pulled back (still inflated), the stent remained in the target lesion and the balloon slid out and got stuck to the guiding catheter.The whole system was able to be withdrawn as a single unit with the balloon still inflated.A new guiding catheter was used to successfully complete the procedure.The final result for the patient was good.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.Inspection of the returned device was performed and stretching was observed in multiple areas of the system, implying excessive force likely were imparted onto the delivery system.These stretches could have damaged the balloon inflation lumen such that post inflation it lost its integrity and collapsed, creating the situation where the balloon was unable to deflate post stent deployment.The reported difficult to remove was able to be confirmed.The reported deflation issue was unable to be replicated in a testing environment due to the condition of the returned device.The reported physical resistance was unable to be replicated in a testing environment as it was based on operational circumstances.It should be noted that the xience pro x everolimus eluting coronary stent system instructions for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged when retracting the undeployed stent back into the guiding catheter.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 incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and subsequent use error.Manipulation of the device and/or interaction with the anatomy and/or other devices as the device was removed then reinserted (against the ifu) resulted in the multiple noted stretched shaft locations thereby reducing the inflation/ deflation lumen; thus after the compromised device was reinserted and attempted to be deflated resulted in the reported deflation issue.Interaction with the guiding catheter during attempt to remove the inflated device resulted in the noted device damages (longitudinal scratches on the outer member, tear in the inner member at the stretched portion of the shaft, shaft kink) thus resulting in the noted leak out of the guide wire exit notch during return analysis.A cine of the procedure was received and reviewed by an abbott vascular clinical specialist who concluded that a non-abbott guiding catheter was used after the initial delivery attempt of the stent failed.To use the second guiding catheter the xience pro stent delivery system would need to be completely removed from the coronary anatomy and out of the initial guiding catheter.As there was difficulty during the initial delivery it is conceivable that there was some damage done to the catheter shaft which might not have been noticed upon removal to use the new guide cathetr.Multiple movements in and out of the guiding catheter can cause damage (visible or not) to the delivery system.Reuse of a stent delivery system after it has been retracted into the guiding catheter should not be done as well, as per the ifu.Additionally, the compatibility of the xience pro and the 2nd guide catheter has not been evaluated for use.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
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7022611
• MDR Text Key: 92862507
• Report Number: 2024168-2017-08888
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 1076350-33
• Device Lot Number: 7072041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1