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

Catalog Number 1234300-28

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

Patient Problems Angina (1710); Cardiac Arrest (1762); Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Stenosis (2263); Respiratory Failure (2484); Test Result (2695)

Event Date 04/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.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 angina, cardiac arrest, hypotension, thrombosis and restenosis, as listed in the absorb gt1 instructions for use (ifu) are known adverse events associated with the use of a coronary scaffold in native coronary arteries.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 and there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that on (b)(6) 2015, a 3.0x28mm and 3.0x12mm absorb gt1 bioresorbable vascular scaffold (bvs) were successfully implanted in the proximal right coronary artery (rca) lesion.On (b)(6) 2016, the patient started experiencing stable angina and was referred for an angiogram.Per angiogram, both the proximal rca scaffolds were occluded with stenosis.On (b)(6) 2016, an elective rca pci was performed with stent placement.During the procedure, the patient developed chest pain, hypotension and went into cardiac arrest.Cardiopulmonary resuscitation (cpr) was performed.Per imaging, the left main (lm) segment had occluded.An unspecified stent was implanted in the lm during cpr.Thrombus was then noted in the lm stent.Balloon angioplasty was performed as treatment and the circulation was restored.The patient went into a third cardiac arrest.A loss of blood flow was noted in the rca.A scan was performed showing a hematoma around the left atrium and an lad dissection.A balloon pump was placed and medications was provided.The patient developed severe acidosis during the cardiac arrests.Critical care was required along with prolonged hospitalization.On (b)(6) 2016, elevated creatine kinase (ck) was noted.On (b)(6) 2016, the event resolved and the patient was discharged from the hospital.Per physician, the event was possibly caused by scaffold thrombosis.There was no additional information provided.

Manufacturer Narrative

Internal file number - (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.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 and treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filled medwatch report, additional information was obtained: during the (b)(6) 2016 event, the patient was placed on ventilation.Hemofiltration was performed and a nasogastric (ng) tube was inserted.During this event, a pleural effusion was also noted.On (b)(6) 2016, the patient expressed experiencing exertional chest discomfort.A stress echocardiogram was performed with negative results.On (b)(6) 2017, the patient expressed exertional angina again.A diagnostic angiogram was performed due to possible re-stenosis.The lm unspecified stent was patent with malapposition of this unspecified stent.The lad and cx were unobstructed.The rca was occluded proximally with retrograde filing from a large lad collateral.Lifelong dapt was discussed and a possible coronary artery bypass or another percutaneous coronary intervention is possible in the future.

• 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: 6079574
• MDR Text Key: 59192104
• Report Number: 2024168-2016-07599
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648212826
• UDI-Public: (01)08717648212826(17)161005(10)5041061
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2016
• Device Catalogue Number: 1234300-28
• Device Lot Number: 5041061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2018
• 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
• Treatment: ASPIRIN, P2Y123.0X12MM SCAFFOLD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 79