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

Catalog Number 1234350-23

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 08/02/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Concomitant medical products: other: absorb gt1 3.0x28mm stent: xience (3.5x38mm, 3.0x28mm) (b)(4).The scaffold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The rx absorb gt1 3.0 x 28 mm is being filed under a separate manufacturer report number.

Event Description

It was reported that the procedure on (b)(6) 2016 was to treat the ostial to mid left anterior descending (lad) artery.The patient had been experiencing chest discomfort and dyspnea on exertion for one month.No imaging was done for vessel sizing.After pre-dilatation, two absorb gt1 scaffolds (3.0x28mm, 3.5x23mm) were implanted overlapping and post-dilated.Final angiographic results showed residual stenosis <10%.The patient returned on 02-aug-2016 for scheduled follow-up and while in the hospital the patient experienced severe angina and cardiac arrest.Resuscitation and cpr was performed for 20 minutes.Emergency percutaneous coronary intervention was performed and angiogram revealed acute scaffold thrombosis.The patient was given an ic streptokinase.Two xience stents (3.5x38mm, 3.0x28mm) were implanted overlapping and covered both scaffolds to restore timi iii flow.The patient remained unstable after the procedure and remained under observation.It was also thought that the patient had not been compliant with dual antiplatelet drug therapy (dapt) after the initial procedure.The patient condition deteriorated on (b)(6) 2016 with oliguria secondary to acute renal failure and rhabdomyolysis.The patient had low blood count after the procedure, but refused a transfusion.The patient died on (b)(6) 2016.Cause of death was multi-organ failure and septicemia, secondary to acute myocardial infarction.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 angina, cardiac arrest, death, myocardial infarction and thrombosis, 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 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

Additional information: no imaging was done for vessel sizing; however, the vessel was visually assessed to be >4mm.

Manufacturer Narrative

(b)(4).Correction: the date filed on the initial medwatch report should have been (b)(6) 2016, not (b)(6) 2016.

• 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: 5905353
• MDR Text Key: 53036640
• Report Number: 2024168-2016-05710
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2016
• Device Catalogue Number: 1234350-23
• Device Lot Number: 5091061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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