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

Catalog Number 1125225-15

Device Problems Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2017

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 was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the ramus artery with moderate calcification and moderate tortuosity.The lesion was pre-dilated with a 2.0x15mm trek balloon dilatation catheter (bdc).An attempt was made to advance the 2.25x15mm rx xience alpine stent delivery system (sds); however the device would not cross and was removed from the anatomy.A guideliner was placed and the same alpine sds was successfully positioned in the lesion.The device was prepped inside the anatomy.When inflated to 10 atmospheres, the stent seemed to expand, but the device would not hold pressure.The sds was removed without issue.An attempt was made to post-dilate the stent; however, the 2.5x6mm nc trek was unable to cross the lesion due to a bend in the anatomy.It was confirmed under angiography that the stent was expanded with no waist.No further treatment was attempted and the procedure was completed.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the device was returned for analysis.The reported failure to deploy was able to be confirmed.The reported physical resistance was unable to be replicated in a testing environment as it was based on operational circumstances.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.It should be noted that the xience alpine 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.In addition, reportedly the device was prepped inside the anatomy.The ifu states to flush the guide wire lumen and prepare the device by removing air from the system prior to use.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and subsequent use error as it is likely that as the stent delivery system was advanced resistance was met with the moderately calcified and moderately tortuous anatomy resulting in the reported physical resistance.As the device was removed, then reinserted into the anatomy and prepped inside the anatomy, manipulation of the device and/or interaction with other devices/guidewire resulted in the noted slightly bent shaft and the noted inner member hole, thus resulting in the report failure to deploy.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

(b)(4).The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the sds was advanced resistance was met with the moderately calcified and moderately tortuous anatomy resulting in the reported physical resistance.As the device was removed, then reinserted into the anatomy manipulation of the device and/or interaction with the guidewire resulted in the noted slightly bent shaft and the noted inner member hole thus resulting in the report failure to deploy.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING 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: 6812323
• MDR Text Key: 83704132
• Report Number: 2024168-2017-06864
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2020
• Device Catalogue Number: 1125225-15
• Device Lot Number: 7053141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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
• Patient Age: 67 YR