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

Catalog Number 1125300-18

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the right coronary artery, with moderate tortuosity and heavy calcification.Pre-dilatation was performed.A 3.0x18mm xience alpine stent delivery system (sds) was prepped for use and air aspiration was performed outside the patient anatomy.No issues were noted at that time.The 3.0x18mm xience alpine sds was advanced but failed to cross the lesion due to resistance with the anatomy.Several attempts were made to cross the lesion.Double wire technique was used and the 3.0x18mm xience alpine sds was removed for further pre-dilatation.The 3.0x18mm xience alpine sds was re-inserted and the 3.0x18mm xience alpine sds finally crossed the lesion.Negative was pulled before the 3.0x18mm xience alpine sds was pressurized, and blood was observed coming into the indeflator.Thus, the 3.0x18mm xience alpine sds was removed from the patient anatomy.The procedure was completed with a new non-abbott sds.No adverse patient effect was reported and no clinically significant delay in the procedure was reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Unique device identifier (udi): (b)(4).Evaluation summary: the device was returned for analysis.The reported leak 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.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 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 electronic instructions for use 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: 5154930
• MDR Text Key: 28721568
• Report Number: 2024168-2015-06103
• 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: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2017
• Device Catalogue Number: 1125300-18
• Device Lot Number: 4120941
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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: 77 YR
• Patient Weight: 63