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

Catalog Number 1125350-15

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure to treat a lesion in the distal right coronary artery with heavy tortuosity and heavy calcification, a 3.5x15 mm rx xience alpine stent delivery system (sds) was advanced but could not cross the lesion due to the patient anatomy.The sds was withdrawn and an attempt was made to re-advance the sds again after insertion of a non-abbott guide catheter extension into the patient anatomy.However, the sds got stuck at the proximal end of the non-abbott guide catheter extension lumen and even after pushing and pulling the xience alpine sds repeatedly, the sds could not advance into the lumen of the non-abbott guide catheter extension.Reportedly, the stent moved and was misaligned on the balloon.The sds was removed by itself from the patient anatomy; resistance was felt with the non-abbott guide catheter extension and resistance was felt with the y-connector (rotating hemostatic valve-rhv).Reportedly, the stent dislodged inside of the rhv.The dislodged stent was able to be simply removed from the rhv.The non-abbott guide catheter extension was replaced with a new non-abbott catheter and the target lesion was treated with a new 3.5x15 mm rx xience alpine sds.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Against resistance, re-insertion.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The device was returned for analysis.The reported dislodged stent was able to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.The reported difficulty to position, the reported difficulty to remove the device using a guiding catheter extension and the reported difficulty to remove the device using a rotating hemostatic valve (rhv) was unable to be replicated in a testing environment due to the condition of the returned device.Based on a visual, dimensional and functional inspection of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the information provided, the reported difficulties appear to be related to circumstances of the procedure and not a product quality issue with respect to manufacture, design or labeling.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot specific quality issue.It should be noted that the xience alpine eluting coronary stent system electronic instructions for use (ifu) states: note: if unusual resistance is felt before the stent exits the guiding catheter, do not force passage.Resistance may indicate a problem and the use of excessive force may result in stent damage or dislodgement.Maintain guide wire placement across the lesion and remove the delivery system and guiding catheter as a single unit.Additionally, it should be noted that the xience alpine eluting coronary stent system electronic 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 or and dislodged from the balloon when retracting the undeployed stent back into the guiding catheter.Based on the information reviewed, there is no evidence to indicate the presence a potential 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: 4957204
• MDR Text Key: 16206916
• Report Number: 2024168-2015-04299
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor,company represent
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2018
• Device Catalogue Number: 1125350-15
• Device Lot Number: 5011241
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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