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

Catalog Number 1120350-33

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Numbness (2415)

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.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 moderately tortuous, heavily calcified de novo mid circumflex artery.Radial access was used.Pre-dilatation was performed with an unspecified 2.0 mm balloon catheter.A 3.5 x 33 mm xience alpine stent was being advanced to the lesion; however, it could not cross.During withdrawal, there was resistance when the stent was re-entering the guiding catheter so the entire system was removed together.When the devices got to the radial sheath, the stent dislodged and went into the radial artery.An attempt was made to remove the stent but it remained in the radial artery.They moved to the femoral artery to complete the case where two 3.5 x 18 mm xience alpine stents were implanted in the circumflex.When the patient returned to the critical care unit, the patient had tingling in the hand and surgery was performed to remove the dislodged stent.The patient was discharged the same day.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4) the device was not returned for evaluation.A cine was received and reviewed by an abbott vascular clinical specialist.The imaging shows a close-up of the deployed stent with the delivery system almost fully removed from the deployed stent.There are not any images of the loose undeployed stent in the radial artery.In conclusion, it is confirmed that the patient had a loose stent in the radial artery as the stent was surgically removed.The loss of the stent from the delivery system is not within the imaging provided and thus it is not possible to determine a probable cause.It is likely that the stent was damaged when trying to be delivered past the calcific region of the artery and as a result unable to be removed first through the guide catheter and then secondarily through the introducer sheath.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.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: 6718612
• MDR Text Key: 80202878
• Report Number: 2024168-2017-05937
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 1120350-33
• Device Lot Number: 7012441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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 Outcome(s): Required Intervention