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

Catalog Number 1125300-23

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578); Material Twisted/Bent (2981)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); Shock (2072); Diminished Pulse Pressure (2606)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A same size xience alpine was used to successfully complete the procedure and the patient was in a stable condition.Afterwards it was also noted that the shaft of the 3.0x23 xience alpine sds was confirmed to be wrinkled, about 3-5cm distal to the gw port.No additional information was provided.(b)(4)./ concomitant product(s): dilatation catheter: 2.0x12mm kamui.Guide wire: runthrough; ultra floppy.Stent: 2.25x 12 xience alpin.Evaluation summary: a visual, functional and dimensional inspection was performed on the returned device.The reported shaft leak and twisted (wrinkled) material were confirmed.The reported physical resistance could not be tested as it was based on operational circumstances.The reported patient effects of hypotension and shock are listed in the xience alpine everolimus eluting coronary stent systems (eecss) instructions for use (ifu) as known patient effects of coronary stenting procedures.The xience alpine everolimus eluting coronary stent system (eecss)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 did not indicate a lot specific quality issue.The investigation determined that 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 the design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was to treat a moderately tortuous, moderately calcified concentric de novo lesion in the distal circumflex that was 90% stenosed.A non-abbott guide wire (gw) was advanced to the first marginal(om) and pre-dilatation was performed with a 2.0x12mm non-abbott balloon dilatation catheter (bdc).Then a 2.25x12mm xience alpine stent was deployed in the om.A non-abbott gw was then advanced to the distal left circumflex and pre-dilatation was performed with a 2.75x13mm non-abbott balloon catheter.A 3.0x23mm xience alpine stent delivery system (sds) was then advanced but was unsuccessful, possibly due to interaction with the previously deployed stent.The implanted stent was then post-dilated with a 2.0x12mm non-abbott bdc at high pressures.The non-abbott bdc was left in the om to be used for kissing balloon technique afterwards.The 3.0x23mm xience alpine sds was advanced again and met resistance at the bifurcation.The balloon was removed and the 3.0 x 23mm xience alpine was able to cross.An attempt was made to pressurize the 3.0x23mm xience alpine sds, but pressure indication on the indeflator was unable to increase due to a leak on the shaft of the sds, around the gw exit notch.As the sds was being pressurized, contrast media leaked from the shaft, into the inner lumen of the guiding catheter (gc) which resulted in leaked contrast while pushing air inside the gc and into the vessel.Attempting to pressurize, the patients blood pressure began to drop.Air embolization occurred and the patient entered a state of shock.Blood pressure and pulse dropped to around 20.Atropine sulfate hydrate was administered and blood pressure improved.

• 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: 7043371
• MDR Text Key: 92461583
• Report Number: 2024168-2017-09065
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199363
• UDI-Public: 08717648199363
• 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,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2020
• Device Catalogue Number: 1125300-23
• Device Lot Number: 7060741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/17/2017
• 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 Outcome(s): Required Intervention