MAUDE Adverse Event Report: AV-TEMECULA-CT MULTI-LINK 8; CORONARY STENT SYSTEM

Catalog Number 1012169-23

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Positioning Failure (1158); Inflation Problem (1310)

Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969); Occlusion (1984); Foreign Body In Patient (2687)

Event Date 07/21/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).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 de novo lesion in the proximal circumflex artery.A 4x23mm multi-link 8 rx stent system stylet/protective sheath was removed without resistance.The device was prepped (air aspiration) outside the anatomy prior to use and the contrast mix was 50/50.After pre-dilating the lesion, the multi-link 8 was advanced toward the target lesion.An attempt was made to inflate the balloon and the balloon partially inflated.Reportedly, the device was inflated up to 10 atmospheres for 32 seconds and a second time up to 4 atmospheres for 4 seconds.The stent was partially deployed.An attempt was made to deflate the balloon by applying negative pressure and the balloon partially deflated.The stent system was pulled and the shaft broke in the patient vessel.Failed attempts were made to retrieve the separated portion using a guide catheter and balloon technique.The patient was sent to surgery.The patient became symptomatic with cardiac arrest and myocardial infarction (mi).Failed attempts were made to treat the symptoms via cardiopulmonary resuscitation (cpr), medication, and an intra-aortic balloon pump catheter.The patient expired.The physician indicated that the cause of death was due to mi caused by occlusion of the balloon that remained inflated.No additional information was provided.

Manufacturer Narrative

(b)(4).A visual inspection was performed on the returned device.The reported shaft separation was confirmed.The reported failure to deploy (partial stent deployment), deflation issue (partial) and inflation issue (incomplete) could not be tested due to the condition of the returned device.A cine of the procedure was received and analyzed by an abbott clinical specialist who concluded the following: the shaft separation of the ml8 sds is confirmed.Partial deflation of the sds balloon is confirmed as the shaft is separated and contrast remains in the proximal balloon.Partial deployment of the stent cannot be confirmed with this image.The stent appears fully deployed in the image provided but the quality of the image is suspect and no other views are provided.Partial inflation as reported cannot be confirmed with this image.Images of the inflation are not provided and thus cannot be confirmed.A conclusive cause for the reported failure to deploy (partial stent deployment), deflation issue (partial) and inflation issue (incomplete) cannot be determined.The reported shaft separation and subsequent treatments appear to be related to circumstances of the procedure; however, the reported patient effects, and the relationship to the product, if any, cannot be determined.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 incidents.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: MULTI-LINK 8
• Type of Device: 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: 5879876
• MDR Text Key: 52241359
• Report Number: 2024168-2016-05445
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P020047
• 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: 09/07/2016

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: 06/30/2018
• Device Catalogue Number: 1012169-23
• Device Lot Number: 5072841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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
• Patient Outcome(s): Death