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

Catalog Number 1125400-08

Device Problems Difficult to Remove (1528); Physical Resistance (2578); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient presented with a proximal left anterior descending (lad) coronary artery with a severe takeoff and heavily calcified lesion.Two unspecified "buddy" wires were placed in the lad to 'straighten' the vessel.Following, a 4.0x8mm xience alpine stent delivery system (sds) was advanced with resistance due to anatomy to the lesion site.As the buddy wire was removed from the guide catheter and outside of the sds, the xience alpine stent "shot forward".While the xience alpine sds was pulled back, the stent caught on some calcium and dislodged off the balloon.Additional balloon angioplasty was performed and the stent was expanded up to a 4.0.The stent remains well apposed at an unintended site and another stent was placed at the lesion site.Reportedly, the issues were due to the patients tortuous anatomy and extreme calcification.There was no adverse patient sequela and no clinically significant delay.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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 similar incidents from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the difficult anatomy causing the reported physical resistance.One of two buddy wires was removed causing the reported device operating differently than expected (stent shot forward).The device was pulled back and the stent interacted with the calcified anatomy causing the reported difficulty to remove and subsequent stent dislodgement with the patient effects of foreign body in patient and additional therapy/non-surgical treatment.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: 7606059
• MDR Text Key: 111213280
• Report Number: 2024168-2018-04502
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2021
• Device Catalogue Number: 1125400-08
• Device Lot Number: 8021941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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
• Treatment: GUIDE CATH: EBU 3.75
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 100