MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1012464-28

Device Problems Deflation Problem (1149); Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Folded (2630)

Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817); Thrombosis (2100)

Event Date 04/30/2014

Event Type  Injury  

Event Description

It was reported that prior to the procedure, the patient presented to the hospital with a left ventricular (lv) thrombus and strong left anterior descending (lad) coronary artery stenosis in the proximal lad, 80% with thrombotic material.The last third of the lad was fully closed by thrombotic material and the patient was also diagnosed with an st-elevated myocardial infarction (stemi).On (b)(6) 2014, an emergency percutaneous intervention was performed.During the procedure, antiplatelet medications were given and multiple thrombectomies were performed.After pre-dilatation, 30% stenosis was left.A 3.5x28mm drug eluting coronary device was implanted in the proximal lad.Post implantation, resistance was met upon delivery system removal from the scaffold.Once the delivery system was outside the anatomy, the balloon was noted to be partially inflated and did not properly refold.Per intra-vascular ultrasound (ivus), suboptimal wall apposition, of the implanted scaffold, was noted.Post dilatation was performed and the scaffold was fully apposed to the vessel wall, completing the procedure.Per ivus, 100% stenosis remained in the distal third of the lad.The patient was placed on antiplatelet medications.On (b)(6) 2014, the patient developed angina, and per electrocardiogram, st-elevation.A diagnostic angiogram was performed showing an in-scaffold thrombus.The scaffold remained well apposed to the vessel wall.The patient was re-wired and thrombus aspiration was performed multiple times.The patient also received thrombolytic medications.After aspirations, thrombotic material was still present, so a 3.5x28mm xience pro was successfully implanted, with good results.The patient was transferred to the intensive care unit and reportedly is currently in good condition and continuing antiplatelet medications.There was no additional information provided.

Event Description

Subsequent to the initial medwatch report, the following information was received: during the index procedure and after pre-dilatation, one third of the distal lad remained occluded.During the index procedure, post-dilatation of the implanted device, was performed using a 3.75x15mm non-abbott device.After post-dilatation, small amounts of residual thrombus remained at the scaffold site.After the procedure, the patient was transferred to the intensive care unit and reportedly, remains in good condition and is continuing antiplatelet medications.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Though the device is not approved for sale in the u.S., it uses a delivery system which is similar to a device sold in the u.S.The pma# listed is based on the predicate device (xience v stent system) that is determined to be same and similar to the delivery system of this device.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported balloon refold issue was confirmed.The reported deflation issue was not confirmed.The reported difficulty to deploy and difficult to remove could not be replicated in a testing environment as they were based on operational circumstances.Based on the visual, dimensional and functional analysis of the device, there is no indication of a product deficiency.A cine file, sent with the case, was reviewed by an abbott vascular physician.The review confirmed that the device looked well apposed and expanded at the implant procedure.Pictures were not provided for the post procedure thrombosis.No device deficiencies were seen.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A review of the complaint history of the reported lot did not indicate a manufacturing issue.The reported patient effects of angina and thrombosis, as listed in the device instructions for use (ifu), are known patient effects that may be associated with the use of the drug eluting coronary stent system in native coronary arteries.A review of the labels attached to the lot history record for this lot was conducted and the label review indicated that the use-by (expiration) date of the device was 03-january-2014.However, the device was implanted on (b)(6) 2014 which is approximately 4 months post expiration.It should be noted that the ifu instructs the physician to: note the product use-by (expiration) date on the package.Based on the information reviewed, there is no indication of a product deficiency.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3844151
• MDR Text Key: 4655061
• Report Number: 2024168-2014-03539
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2014

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: 01/03/2014
• Device Catalogue Number: 1012464-28
• Device Lot Number: 3070861
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 06/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 110