MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1234350-18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Ventricular Fibrillation (2130); Stenosis (2263)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient presented with an st-elevated myocardial infarction (stemi) analog.The procedure on (b)(6) 2016 was to treat a lesion located in the right coronary artery (rca) with 60% stenosis.Vessel sizing was done with intravascular ultrasound (ivus).Predilation was performed with a 3.5mm balloon catheter at 12 atmospheres (atm).The residual stenosis was reduced to less than 40%.A 3.5x18mm absorb gt1 was implanted and post-dilated with a 3.5x16mm non-compliant balloon catheter.The final angiographic residual stenosis was less than 10%.Imaging was used to confirm that the scaffold was fully apposed to the vessel wall.The patient was placed on dual anti-platelet therapy consisting of ticagrelor and aspirin.On (b)(6) 2016 the patient was out walking when they went into cardiac arrest.The patient was resuscitated with cardiopulmonary resusitation.The procedure showed a tight stenosis proximal to the absorb scaffold, possibly within 5 mm of the scaffold.The stenosis was treated with an unspecified drug eluting stent.An air embolus was noted during the procedure and the patient experienced ventricular fibrillation.The patient was treated with defibrillation and flushing saline.An angiography of the rca was performed and it was fine.The patient was discharged on (b)(6) 2016.The patient was seen on (b)(6) 2016 and was well with no complaints.As of (b)(6) 2016, the patient was alive.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of air embolism, cardiac arrest, thrombosis, ventricular fibrillation and restenosis, as listed in the absorb gt1 instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.

Event Description

Subsequent to the previously filed medwatch report, additional information was received stating that during the index procedure, intravascular ultrasound was used to confirm the absorb scaffold was fully apposed to the vessel wall.In addition to restenosis noted on april 7, 2016, there was also thrombosis possibly related to the absorb.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• 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: 6100695
• MDR Text Key: 59834774
• Report Number: 2024168-2016-07940
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P150023
• 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,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2016
• Device Catalogue Number: 1234350-18
• Device Lot Number: 5042261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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): Hospitalization; Life Threatening; Required Intervention