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

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

Patient Problems Death (1802); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 08/16/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded: extensive scaffold thrombosis in both lad and lcx, extending proximal, within and distal to scaffold in each case.Despite extensive thrombectomy, the patient died later that night.Anti-thrombotic status unclear at time of death.The reported patient effects of death, myocardial infarction and thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot numbers were not provided.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The other absorb device is being filed under a separate medwatch report.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.

Event Description

It was reported that the patient had triple vessel disease.In (b)(6) 2014, the patient had an absorb scaffold implanted in the proximal left anterior descending (lad) artery.In (b)(6) 2015 an absorb scaffold was implanted in the proximal left circumflex (lcx) artery.Both procedures were done at cgmh-lk.On an unspecified date, a drug eluting stent (des) was implanted in the right coronary artery (rca).On (b)(6) 2017, the patient presented to the emergency room at (b)(6) hospital with st elevated myocardial infarction.Thrombosis was found in both scaffolds, but not in the des.The thrombosis was aspirated followed by balloon dilatation with 2.0 x 20 mm and 2.0 x 15 mm balloons.The decision was made to do a stage 2 procedure, but the patient died that night in the hospital.No additional information was provided.

• Brand Name: ABSORB 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: 6850435
• MDR Text Key: 85264359
• Report Number: 2024168-2017-07341
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 77 YR