MAUDE Adverse Event Report: AV-TEMECULA-CT ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

Catalog Number 1003382-18

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158); Difficult to Remove (1528); Material Rupture (1546)

Patient Problems Bradycardia (1751); Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The 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 mid and proximal right coronary artery.The prowater guidewire was unable to cross due to the patient anatomy.The guide wire was removed without issue and was replaced with a non-abbott guide wire.Throughout the case, the patient was intermittently pacing indicating that he was persistently bradycardic.A 5.0x18 rx ultra stent delivery system (sds) was advanced and during the first inflation, the balloon ruptured, and the stent was unable to be deployed.The stent remained on the balloon; resistance was felt with the guide catheter.The delivery catheter could not be retracted through the guide catheter and the sds shaft separated.The guide catheter and delivery system were successfully removed together.The patient began to experience ekg changes and st elevation myocardial infarction.A 4.5x28mm and a 5.0x13 mm ultra stents were successfully implanted, the patient symptoms all resolved.The procedure was prolonged.The patient is stable.No additional information was provided.

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection was performed on the returned device.The reported shaft detachment and failure to deploy were confirmed.The reported material rupture could not be confirmed.The reported difficult to remove (guide catheter) could not be tested as it was based on operational circumstances.The investigation determined a conclusive cause for the reported failure to deploy and material rupture cannot be determined; however, the reported difficult to remove and shaft detachment appear to be related to the circumstances of the procedure.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The reported patient effect of myocardial infarction as listed in ultra rapid exchange (rx) coronary stent system, instructions for use is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM
• Type of Device: CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6530422
• MDR Text Key: 73957237
• Report Number: 2024168-2017-03761
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2017

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 Catalogue Number: 1003382-18
• Device Lot Number: 6120941
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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; Disability